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Meta-Analysis
. 2012 May 16;2012(5):CD002314.
doi: 10.1002/14651858.CD002314.pub3.

Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children

Bhupendrasinh F Chauhan  1 , Francine M Ducharme
Affiliations
Meta-Analysis

Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children

Bhupendrasinh F Chauhan et al. Cochrane Database Syst Rev. .

Abstract

Background: Anti-leukotrienes (5-lipoxygenase inhibitors and leukotriene receptors antagonists) serve as alternative monotherapy to inhaled corticosteroids (ICS) in the management of recurrent and/or chronic asthma in adults and children.

Objectives: To determine the safety and efficacy of anti-leukotrienes compared to inhaled corticosteroids as monotherapy in adults and children with asthma and to provide better insight into the influence of patient and treatment characteristics on the magnitude of effects.

Search methods: We searched MEDLINE (1966 to Dec 2010), EMBASE (1980 to Dec 2010), CINAHL (1982 to Dec 2010), the Cochrane Airways Group trials register, and the Cochrane Central Register of Controlled Trials (Dec 2010), abstract books, and reference lists of review articles and trials. We contacted colleagues and the international headquarters of anti-leukotrienes producers.

Selection criteria: We included randomised trials that compared anti-leukotrienes with inhaled corticosteroids as monotherapy for a minimum period of four weeks in patients with asthma aged two years and older.

Data collection and analysis: Two review authors independently assessed the methodological quality of trials and extracted data. The primary outcome was the number of patients with at least one exacerbation requiring systemic corticosteroids. Secondary outcomes included patients with at least one exacerbation requiring hospital admission, lung function tests, indices of chronic asthma control, adverse effects, withdrawal rates and biological inflammatory markers.

Main results: Sixty-five trials met the inclusion criteria for this review. Fifty-six trials (19 paediatric trials) contributed data (representing total of 10,005 adults and 3,333 children); 21 trials were of high methodological quality; 44 were published in full-text. All trials pertained to patients with mild or moderate persistent asthma. Trial durations varied from four to 52 weeks. The median dose of inhaled corticosteroids was quite homogeneous at 200 µg/day of microfine hydrofluoroalkane-propelled beclomethasone or equivalent (HFA-BDP eq). Patients treated with anti-leukotrienes were more likely to suffer an exacerbation requiring systemic corticosteroids (N = 6077 participants; risk ratio (RR) 1.51, 95% confidence interval (CI) 1.17, 1.96). For every 28 (95% CI 15 to 82) patients treated with anti-leukotrienes instead of inhaled corticosteroids, there was one additional patient with an exacerbation requiring rescue systemic corticosteroids. The magnitude of effect was significantly greater in patients with moderate compared with those with mild airway obstruction (RR 2.03, 95% CI 1.41, 2.91 versus RR 1.25, 95% CI 0.97, 1.61), but was not significantly influenced by age group (children representing 23% of the weight versus adults), anti-leukotriene used, duration of intervention, methodological quality, and funding source. Significant group differences favouring inhaled corticosteroids were noted in most secondary outcomes including patients with at least one exacerbation requiring hospital admission (N = 2715 participants; RR 3.33; 95% CI 1.02 to 10.94), the change from baseline FEV(1) (N = 7128 participants; mean group difference (MD) 110 mL, 95% CI 140 to 80) as well as other lung function parameters, asthma symptoms, nocturnal awakenings, rescue medication use, symptom-free days, the quality of life, parents' and physicians' satisfaction. Anti-leukotriene therapy was associated with increased risk of withdrawals due to poor asthma control (N = 7669 participants; RR 2.56; 95% CI 2.01 to 3.27). For every thirty one (95% CI 22 to 47) patients treated with anti-leukotrienes instead of inhaled corticosteroids, there was one additional withdrawal due to poor control. Risk of side effects was not significantly different between both groups.

Authors' conclusions: As monotherapy, inhaled corticosteroids display superior efficacy to anti-leukotrienes in adults and children with persistent asthma; the superiority is particularly marked in patients with moderate airway obstruction. On the basis of efficacy, the results support the current guidelines' recommendation that inhaled corticosteroids remain the preferred monotherapy.

PubMed Disclaimer

Conflict of interest statement

Bhupendrasinh Chauhan ‐ none known.

Prof. Francine Ducharme has received travel support, research funds and fees for speaking from Glaxo SmithKline, Novartis, Nycomed, and Merck Frosst Inc.

Figures

1
1
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
2
2
Forest plot of comparison: 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), outcome: 1.1 Patients with at least one exacerbation requiring systemic steroids.
3
3
In the control group (on ICS) 7 people out of 100 had at least one exacerbation requiring systemic steroids over 4 to 52 weeks, compared to 10 (95% CI 8 to 13) out of 100 for the active treatment group given LRTA.
4
4
Funnel plot of comparison: 1 Anti‐leukotriene (AL) versus. Inhaled glucocorticoids (in HFC‐BDP equivalent), outcome: Patients with at least 1 exacerbation requiring systemic corticosteroids.
5
5
In the control group (on ICS) 2 people out of 100 had withdrawal due to poor control over 4 to 52 weeks, compared to 6 (95% CI 4 to 7) out of 100 for the active treatment group (given LRTA).
1.1
1.1. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 1 Patients with at least one exacerbation requiring systemic steroids.
1.2
1.2. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 2 Patients with at least one exacerbation requiring hospital admission.
1.3
1.3. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 3 Change from baseline FEV1 (L) at 4 ‐ 8 weeks.
1.4
1.4. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 4 Change from baseline FEV1( L) 12 ‐ 16 weeks.
1.5
1.5. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 5 Change from baseline FEV1 (L) at 24 ‐ 26 weeks.
1.6
1.6. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 6 Change from baseline FEV1 (L) at 36 ‐ 52 weeks.
1.7
1.7. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 7 FEV1 irrespective of time of treatment.
1.8
1.8. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 8 Responders (defined as change from baseline in FEV1 >= 7.5%.
1.9
1.9. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 9 Change from baseline FEV1 (%) at 4 ‐ 8 weeks.
1.10
1.10. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 10 Change from baseline FEV1 (%) 12 ‐ 16 weeks.
1.11
1.11. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 11 Change from baseline FEV1 (%) at 24 ‐ 26 weeks.
1.12
1.12. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 12 Change from baseline FEV1 % of predicted at 4 ‐ 8 weeks.
1.13
1.13. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 13 Change from baseline FEV1 % of predicated at 12 ‐ 16 weeks.
1.14
1.14. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 14 Change from baseline FEV1 % of predicated at 36 ‐ 52 weeks.
1.15
1.15. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 15 Change from baseline AM PEFR (L/min) at 4 ‐ 8 weeks.
1.16
1.16. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 16 Change from baseline AM PEFR (L/min) at 12 ‐ 16 weeks.
1.17
1.17. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 17 Change from baseline AM PEFR (L/min) at 24 ‐ 26 weeks.
1.18
1.18. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 18 Change from baseline AM PEFR (L/min) at 36 ‐ 52 weeks.
1.19
1.19. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 19 Change from baseline daytime symptom scores at 4 ‐ 8 weeks.
1.20
1.20. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 20 Change from baseline daytime symptom scores at 12 ‐ 16 weeks.
1.21
1.21. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 21 Change from baseline daytime symptom scores at 24 ‐ 26 weeks.
1.22
1.22. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 22 Change from baseline daytime symptom scores at 36 ‐ 52 weeks.
1.23
1.23. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 23 Change from baseline night‐time awakenings at 4 ‐ 8 week.
1.24
1.24. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 24 Change from baseline night‐time awakenings at 12 ‐ 16 weeks.
1.25
1.25. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 25 Change from baseline night‐time awakenings at 24 ‐ 26 weeks.
1.26
1.26. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 26 Change from baseline mean daily use of β2‐agonists at 4 ‐ 8 weeks.
1.27
1.27. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 27 Change from baseline mean daily use of β2‐agonists at 12 ‐ 16 weeks.
1.28
1.28. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 28 Change from baseline mean daily use of β2‐agonists at 24 ‐ 26 weeks.
1.29
1.29. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 29 Change from baseline mean daily use of β2‐agonists at 36 ‐ 52 weeks.
1.30
1.30. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 30 Change in rescue‐free days (%) at 4 ‐ 8 weeks.
1.31
1.31. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 31 Change in rescue‐free days (%) at 12 ‐ 16 weeks.
1.32
1.32. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 32 Change in rescue‐free days (%) at 24 ‐ 26 weeks.
1.33
1.33. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 33 Change in rescue‐free days (%) at 36 ‐ 52 weeks.
1.34
1.34. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 34 Change in proportion of symptom‐free days (%) at 4 ‐ 8 weeks.
1.35
1.35. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 35 Change in proportion of symptom‐free days (%) at 12 ‐ 16 weeks.
1.36
1.36. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 36 Change in proportion of symptom‐free days (%) at 24 ‐ 26 weeks.
1.37
1.37. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 37 Change in proportion of symptom‐free days (%) at 36 ‐ 52 weeks.
1.38
1.38. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 38 Change from baseline quality of life (QOL) at 4 ‐ 8 weeks.
1.39
1.39. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 39 Change from baseline quality of life (QOL) at 12 ‐ 16 weeks.
1.40
1.40. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 40 Change from baseline quality of life (QOL) at 24 ‐ 26 weeks.
1.41
1.41. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 41 Change from baseline quality of life (QOL) at 36 ‐ 52 weeks.
1.42
1.42. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 42 Days with use of β2‐agonists at 36 ‐ 52 weeks.
1.43
1.43. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 43 Change from baseline blood eosinophils at 4 ‐ 8 weeks.
1.44
1.44. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 44 Change from baseline blood eosinophils at 12 ‐ 16 weeks.
1.45
1.45. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 45 % Change in sputum eosinophils at 4 ‐ 8 weeks.
1.46
1.46. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 46 % Change in sputum eosinophils at 36 ‐ 52 weeks.
1.47
1.47. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 47 LTC4 concentration (ng/mL) in nasal wash at 24 ‐ 26 weeks.
1.48
1.48. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 48 % Asthma control days during intervention period at 4 ‐ 8 weeks.
1.49
1.49. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 49 % Asthma control days during intervention period at 24 ‐ 26 weeks.
1.50
1.50. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 50 Change in PC20 at 4 ‐ 8 weeks.
1.51
1.51. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 51 % rescue ‐ free days at 24 ‐ 26 weeks.
1.52
1.52. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 52 Days off work or school at 24 ‐ 26 weeks.
1.53
1.53. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 53 Change in height (cm).
1.54
1.54. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 54 Patient's satisfaction at 4 ‐ 8 weeks.
1.55
1.55. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 55 Physician's satisfaction at 4 ‐ 8 weeks.
1.56
1.56. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 56 Overall Withdrawals.
1.57
1.57. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 57 Withdrawal due to poor asthma control/exacerbations.
1.58
1.58. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 58 Withdrawals due to adverse effects.
1.59
1.59. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 59 Overall Adverse effects.
1.60
1.60. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 60 Elevated liver enzymes.
1.61
1.61. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 61 Upper respiratory tract infections.
1.62
1.62. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 62 Headache.
1.63
1.63. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 63 Nausea.
1.64
1.64. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 64 Oral candidiasis.
1.65
1.65. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 65 Hoarseness.
1.66
1.66. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 66 Death.
1.67
1.67. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 67 Primary outcome ‐ stratified by anti‐leukotrienes.
1.68
1.68. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 68 Primary outcome ‐ stratified by duration of intervention.
1.69
1.69. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 69 Main outcome ‐stratified by severity of airway obstruction.
1.70
1.70. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 70 Primary outcome ‐ stratified by methodological quality.
1.71
1.71. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 71 Primary outcome‐ stratified by funding source.
1.72
1.72. Analysis
Comparison 1 Anti‐leukotriene (AL) vs. Inhaled glucocorticoids (in HFC‐BDP equivalent), Outcome 72 Primary outcome ‐ stratified by HFC‐BDP equivalent.
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References

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    1. Kumar V, Ramesh P, Lodha R, Pandey RM, Kabra SK. Montelukast vs. inhaled low‐dose budesonide as monotherapy in the treatment of mild persistent asthma: A randomized double blind controlled trial. Journal of Tropical Pediatrics 2007;53(5):325‐30. - PubMed
Laitinen 1997 {unpublished data only}
    1. Laitinen LA, Naya IP, Binks S, Harris A. Comparative efficacy of zafirlukast & low dose steroids in asthmatics on prn beta2‐agonists. European Respiratory Journal. 1997; Vol. 10, issue Suppl 25:419‐20, Abs. 2716.
Laviolette 1999 {published and unpublished data}
    1. Laviolette M, Malmstrom K, Lu S, Chervinsky P, Pujet J‐C, Peszek I, et al. Montelukast added to inhaled beclomethasone in treatment of asthma. American Journal of Respiratory & Critical Care Medicine 1999;160(6):1862‐8. - PubMed
Lazarus 2007 {published data only}
    1. Lazarus SC, Chinchilli VM, Rollings NJ, Boushey HA, Cherniack R, Craig TJ, et al. Smoking affects response to inhaled corticosteroids or leukotriene receptor antagonists in asthma. American Journal of Respiratory and Critical Care Medicine 2007;175(8):783‐90. - PMC - PubMed
Lu 2009 {published data only}
    1. Lu S, Liu N, Dass SB, Reiss TF. A randomized study comparing the effect of loratadine added to montelukast with montelukast, loratadine, and beclomethasone monotherapies in patients with chronic asthma. Journal of Asthma 2009;46(5):465‐9. - PubMed
Malmstrom 1999 {published and unpublished data}
    1. Malmstrom K, Rodriguez‐Gomez G, Guerra J, Villaran C, Pineiro A, Lynn X, et al. Oral montelukast, inhaled beclomethasone, and placebo for chronic asthma: a randomized, controlled trial. Annals of Internal Medicine 1999;130(6):487‐95. - PubMed
Maspero 2001 {published data only}
    1. Maspero JF, Duenas‐Meza E, Volovitz B, Daza CP, Kosa L, Vrijens F, et al. Oral montelukast versus inhaled beclomethasone in 6 to 11‐year old children with asthma: results of an open‐label extension study evaluating long‐term safety, satisfaction, and adherence to therapy. Current Medical Research and Opinion 2001; Vol. 17, issue 2:96‐104. - PubMed
Meltzer 2002 {published data only}
    1. Meltzer EO, Lockey RF, Friedman BF, Kalberg C, Goode‐Sellers S, Srebro S, et al for the Fluticasone Propionale Clinical Research Study Group. Efficacy and safety of low‐dose fluticasone propionate compared with montelukast for maintenance treatment of persistent asthma. Mayo Clinc Proceedings 2002;77:437‐5. - PubMed
MK0479‐332 {unpublished data only}
    1. Merck. Montelukast asthmatic smoker study. Clinicaltrials.Gov 2006.
Nathan 2001 {published data only}
    1. Nathan RA, Bleecker ER, Kalberg C and the Fluticasone Propionate Study Group. A comparison of short‐term treatment with inhaled fluticasone propionate and zafirlukast for patients with persistent asthma. American Journal of Medicine 2001;111:195‐202. - PubMed
NCT00442559 {unpublished data only}
    1. Montelukast in mild asthmatic children with allergic rhinitis. Clinicaltrials.gov 2008.
Ng 2007 {published data only}
    1. Ng DKK, Chan CH, Wu S, Chow PY, Wong LSW, Fu YM, et al. Oral montelukast versus inhaled budesonide in children with mild persistent asthma: A pilot study. The Hong Kong Journal of Paediatrics 2007;12(1):3‐10.
Ostrom 2005 {published data only}
    1. Ostrom NK, Decotiis BA, Lincourt WR, Edwards LD, Hanson KM, Carranza Rosenzweig JR, et al. Comparative efficacy and safety of low‐dose fluticasone propionate and montelukast in children with persistent asthma. Journal of Pediatrics 2005;147((2):213‐20. - PubMed
Overbeek 2004 {published data only}
    1. Overbeek SE, O'Sullivan S, Leman K, Mulder PGH, Hoogsteden HC, Prins J‐B. Effect of montelukast compared with inhaled fluticasone on airway inflammation. Clinical & Experimental Allergy 2004;34(9):1388‐94. - PubMed
Peroni 2005 {published data only}
    1. Peroni D, Bodini A, Miraglia Del Giudice M, Loiacono A, Baraldi E, Boner AL, et al. Effect of budesonide and montelukast in asthmatic children exposed to relevant allergens. Allergy 2005;60(2):206‐10. - PubMed
Peters 2007 {published data only}
    1. Peters SP, Anthonisen N, Castro M, Holbrook JT, Irvin CG, Smith LJ, et al. Randomized comparison of strategies for reducing treatment in mild persistent asthma. New England Journal of Medicine 2007;356(20):2027‐39. - PubMed
Riccioni 2001 {published data only}
    1. Riccioni G, Castronuove M, Benedictis M, Pace‐Palitti V, Gioacchino M, Della Vecchia R, et al. Zafirlukast versus budesonide on bronchial reactivity in subjects with mild‐persistent asthma. International Journal of Immunopathology and Pharmacology 2001;14(2):87‐92. - PubMed
Riccioni 2002a {published data only}
    1. Riccioni G, D'Orazio N, Ilio C, Della Vecchia R, Lorenzo A. Effectiveness and safety of montelukast versus budesonide at various doses on bronchial reactivity in subjects with mild persistent asthma [Efficacia e tollerabilita del montelukast verso budesonide a diverso dosaggio sulla reattivita bronchiale in soggetti con asma di grado lieve‐persistente]. La Clinica terapeutica 2002;153(5):317‐21. - PubMed
Riccioni 2002b {published data only}
    1. Riccioni G, Ballone E, D'Orazio N, Sensi S, Nicola M, Mascio R, et al. Effectiveness of montelukast versus budesonide on quality of life and bronchial reactivity in subjects with mild‐persistent asthma. International Journal of Immunopathology & Pharmacology 2002;15(2):149‐55. - PubMed
Riccioni 2003 {published data only}
    1. Riccioni G, Vecchia RD, D'Orazio N, Sensi S, Guagnano MT. Comparison of montelukast and budesonide on bronchial reactivity in subjects with mild‐moderate persistent asthma. Pulmonary Pharmacology & Therapeutics 2003;16(2):111‐4. - PubMed
Sheth 2001 {published data only}
    1. Sheth K, Edwards L, Srebro S, Rickard K. Effects of baseline pulmonary function on treatment response: low‐dose fluticasone versus zafirlukast. Annals of Allergy, Asthma and IImmunology 2001;86:2001.
Sorkness 2007 {published data only}
    1. Sorkness CA, Lemanske Jr RF, Mauger DT, Boehmer SJ, Chinchilli VM, Martinez FD. Long‐term comparison of 3 controller regimens for mild‐moderate persistent childhood asthma: The Pediatric Asthma Controller Trial. Journal of Allergy & Clinical Immunology 2007;119(1):64‐72. - PubMed
Stelmach 2002a {published data only}
    1. Stelmach I, Jerzynska J, Kuna P. A randomized, double‐blind trial of the effect of glucocorticoid, antileukotriene and beta‐agonist treatment on IL‐10 serum levels in children with asthma. Clinical & Experimental Allergy 2002;32(2):264‐9. - PubMed
Stelmach 2002b {published and unpublished data}
    1. Stelmach I, Grzelewski T, Stelmach W, Majak P, Jerzynska J, Gorski P, et al. Effect of triamcinolone acetonide, montelukast, nedocromil sodium and formoterol on eosinophil blood counts, ECP serum levels and clinical progression of asthma in children [Polish]. Polski Merkuriusz Lekarski 2002;12(69):208‐13. - PubMed
Stelmach 2004 {published data only}
    1. Stelmach I, Majak P, Jerzynska J, Stelmach W, Kuna P. Comparative effect of triamcinolone, nedocromil and montelukast on asthma control in children: A randomized pragmatic study. Pediatric Allergy & Immunology 2004;15(4):359‐64. - PubMed
Stelmach 2005 {published data only}
    1. Stelmach I, Bobrowska‐Korzeniowska M, Majak P, Stelmach W, Kuna P. The effect of montelukast and different doses of budesonide on IgE serum levels and clinical parameters in children with newly diagnosed asthma. Pulmonary Pharmacology & Therapeutics 2005;18(5):374‐80. - PubMed
Stelmach 2007 {published data only}
    1. Stelmach I, Grzelewski T, Bobrowska‐Korzeniowska M, Stelmach P, Kuna P. A randomized, double‐blind trial of the effect of anti‐asthma treatment on lung function in children with asthma. Pulmonary Pharmacology and Therapeutics 2007;20(6):691‐700. - PubMed
Stelmach 2008 {published data only}
    1. Stelmach I, Grzelewski T, Majak P, Jerzynska J, Stelmach W, Kuna P. Effect of different antiasthmatic treatments on exercise‐induced bronchoconstriction in children with asthma. Journal of Allergy Clinical Immunology 2008;121(2):383‐9. - PubMed
Szefler 2005 {published data only}
    1. Szefler SJ, Phillips BR, Martinez FD, Chinchilli VM, Lemanske RF, Strunk RC. Characterization of within‐subject responses to fluticasone and montelukast in childhood asthma. Journal of Allergy and Clinical Immunology 2005;115(2):233‐42. - PubMed
Szefler 2007 {published data only}
    1. Szefler SJ, Baker JW, Uryniak T, Goldman M, Silkoff PE. Comparative study of budesonide inhalation suspension and montelukast in young children with mild persistent asthma. Journal of Allergy and Clinical Immunology 2007;120(5):1043‐50. - PubMed
Tamaoki 2008 {published data only}
    1. Tamaoki J, Isono K, Taira M, Tagaya E, Nakata J, Kawatani K, et al. Role of regular treatment with inhaled corticosteroid or leukotriene receptor antagonist in mild intermittent asthma. Allergy and Asthma Proceedings : the Official Journal of Regional and State Allergy Societies 2008;29(2):189‐96. - PubMed
Yamauchi 2001 {published data only}
    1. Yamauchi K, Tanifuji Y, Pan LH, Yoshida T, Sakurai S, Goto SI, et al. Effects of Pranlukast, a Leukotriene receptor antagonist, on airway inflammation in mild asthmatics. Journal of Asthma 2001;38(1):51‐7. - PubMed
Yurdakul 2003 {published data only}
    1. Yurdakul AS, Taci N, Eren A, Sipit T. Comparative efficacy of once‐daily therapy with inhaled corticosteroid, leukotriene antagonist or sustained‐release theophylline in patients with mild persistent asthma. Respiratory Medicine 2003;97(12):1313‐9. - PubMed
Zedan 2009 {published data only}
    1. Zedan M, Gamil N, El‐Chennawi F, Maysara N, Hafeez HA, Nasef N, et al. Evaluation of different asthma phenotype responses to montelukast versus fluticasone Treatment. Pediatric Asthma, Allergy and Immunology 2009;22(2):63‐9.
Zeiger 2005 {published data only}
    1. Zeiger RS, Bird SR, Kaplan MS, Schatz M, Pearlman DS, Orav EJ. Short‐term and long‐term asthma control in patients with mild persistent asthma receiving montelukast or fluticasone: a randomized controlled trial. American Journal of Medicine 2005;118(6):649‐57. - PubMed
Zeiger 2006 {published data only}
    1. Zeiger RS, Szefler SJ, Phillips BR, Schatz M, Martinez FD, Chinchilli VM. Response profiles to fluticasone and montelukast in mild‐to‐moderate persistent childhood asthma. Journal of Allergy & Clinical Immunology 2006;117(1):45‐52. - PubMed
Zielen 2010 {published data only}
    1. Zielen S, Christmann M, Kloska M, Dogan‐Yildiz G, Lieb A, Rosewich M. Predicting short term response to anti‐inflammatory therapy in young children with asthma. Current Medical Research and Opinion 2010;26(2):483‐92. - PubMed

References to studies excluded from this review

Abbott Pharma 1996 {published data only}
    1. Abbott Pharmaceuticals. Zyflo Filmtab (zileuton) product description. Abbott Laboratories 1996.
Al Frayh 2008 {published data only}
    1. Al Frayh A, Abba A, Iskandarani A, Shaker DS, Zaitoun F, Shahrabani L, et al. Establishing therapeutic bioequivalence of a generic salbutamol (Butalin) metered dose inhaler to Ventolin. Biomedical Research 2008;19(1):61‐8.
Allayee 2007 {published data only}
    1. Allayee H, Hartiala J, Lee W, Mehrabian M, Irvin CG, Conti DV, et al. The effect of montelukast and low‐dose theophylline on cardiovascular disease risk factors in asthmatics. Chest 2007;132(3):868‐74. - PubMed
Allen 1997 {published data only}
    1. Allen A, Georgiou P, Compton C, Walls C, Hibell M, Tomson DJ, et al. Lack of pharmacokinetic and pharmacodynamic interactions between pranlukast (Ultair) and terfenadine. American Thoracic Society. 1997:Abs C49.
Allen‐Ramey 2003 {published data only}
    1. Allen‐Ramey FC, Duong PT, Goodman DC, Sajjan SG, Nelsen LM, Santanello NC, et al. Treatment effectiveness of inhaled corticosteroids and leukotriene modifiers for patients with asthma: an analysis from managed care data. Allergy & Asthma Proceedings 2003;24(1):43‐51. - PubMed
Allen‐Ramey 2004 {published data only}
    1. Allen‐Ramey FC, Anstatt DT, Riedel AA, Markson LE. Greater adherence in montelukast patients compared to those on fluticasone [Abstract]. Journal of Allergy and Clinical Immunology 2004;113(2 Suppl):S158.
Allen‐Ramey 2006 {published data only}
    1. Allen‐Ramey FC, Markson LE, Riedel AA, Sajjan S, Weiss KB. Patterns of asthma‐related health care resource use in children treated with montelukast or fluticasone. Current Medical Research & Opinion 2006;22(8):1453‐61. - PubMed
Altman 1998k {published data only}
    1. Altman LC, Munk Z, Seltzer J, Noonan N, Shingo S, Zhang J, et al. A placebo‐controlled, dose‐ranging study of montelukast, a cysteinyl leukotriene‐receptor antagonist. Journal of Allergy & Clinical Immunology 1998;102:50‐6. - PubMed
Anonymous 1997 {published data only}
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Armour 2007 {published data only}
    1. Armour C, Bosnic‐Anticevich S, Brillant M, Burton D, Emmerton L, Krass I, et al. Pharmacy Asthma Care Program (PACP) improves outcomes for patients in the community. Thorax 2007;62(6):496‐502. - PMC - PubMed
Bacharier 2008 {published data only}
    1. Bacharier LB, Phillips BR, Zeiger RS, Szefler SJ, Martinez FD, Lemanske RF, et al. Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate‐to‐severe intermittent wheezing. The Journal of Allergy and Clinical Immunology 2008;122(6):1127‐35. - PMC - PubMed
Bai 2010 {published data only}
    1. Bai J, Xu PR. Montelukast in the treatment of bronchiolitis, a multi‐center, randomized, three‐blind, placebo‐controlled trial. Chinese Journal of Evidence‐Based Medicine 2010;10(9):1011‐5.
Balatsouras 2005 {published data only}
    1. Balatsouras DG, Eliopoulos P, Rallis E, Sterpi P, Korres S, Ferekidis E. Improvement of otitis media with effusion after treatment of asthma with leukotriene antagonists in children with co‐existing disease. Drugs Under Experimental & Clinical Research 2005;31(SUPPL):7‐10. - PubMed
Baren 2006 {published data only}
    1. Baren JM, Boudreaux ED, Brenner BE, Cydulka RK, Rowe BH, Clark S, et al. Randomized controlled trial of emergency department interventions to improve primary care follow‐up for patients with acute asthma. Chest 2006;129(2):257‐65. - PubMed
Barnes 1996 {published data only}
    1. Barnes NC, Black B, Syrett N, Cohn J. Reduction of exacerbations of asthma in multi‐national clinical trials with zafirlukast (Accolate). Allergy 1996;51(Suppl 30):84.
Barnes 1997 {published data only}
    1. Barnes NC, Jong B, Miyamoto T. Worldwide clinical experience with the first marketed leukotriene receptor antagonist. Chest 1997;111 Suppl(2):52‐60. - PubMed
Barnes 1997b {published data only}
    1. Barnes NC, Pujet J‐C. Pranlukast, a novel leukotriene receptor antagonist: results of the first European, placebo controlled, multicentre clinical study in asthma. Thorax 1997;52:523‐7. - PMC - PubMed
Barnes 2001 {unpublished data only}
    1. Barnes N, Wei LX, Reiss TF, Leff JA, Shingo S, Yu C, et al. Analysis of montelukast in mild persistent asthmatic patients with near‐normal lung function. Respiratory Medicine 2001;95(5):379‐86. - PubMed
Barnes 2007 {published data only}
    1. Barnes ML, Menzies D, Fardon TC, Burns P, Wilson AM, Lipworth BJ. Combined mediator blockade or topical steroid for treating the unified allergic airway. Allergy 2007;62(1):73‐80. - PubMed
Barnes 2007a {published data only}
    1. Barnes N, Laviolette M, Allen D, Flood‐Page P, Hargreave F, Corris P, et al. Effects of montelukast compared to double dose budesonide on airway inflammation and asthma control. Respiratory Medicine 2007;101(8):1652‐8. - PubMed
Bartoli 2010 {published data only}
    1. Bartoli ML, Dente FL, Bancalari L, Bacci E, Cianchetti S, Franco A, et al. Beclomethasone dipropionate blunts allergen‐induced early increase in urinary LTE4. European Journal of Clinical Investigation 2010;40(6):566‐9. - PubMed
Bateman 1995 {published data only}
    1. Bateman ED, Holgate ST, Binks SM, Tarns IP. A multicentre study to assess the steroid‐sparing potential of accolate (zafirlukast; 20 mg bd). Allergy 1995;50 Suppl(26):320, Abs P‐0709.
Bateman 2003 {published data only}
    1. Bateman ED, Akveld M, Ho M. Greater responder rate to fluticasone propionate/salmeterol combination over montelukast plus fluticasone in asthma [abstract]. American Thoracic Society 99th International Conference 2003;B036:H90.
Baumgartner 1999 {published data only}
    1. Baumgartner RA, Polis A, Angner R, Bird S, Reiss TF. Comparison between montelukast and inhaled beclomethasone therapy in chronic asthma: a double blind, placebo controlled, parallel study in asthmatic patients. Merck Research Laboratories 1999.
Benitez 2005 {published data only}
    1. Benitez HH, Arvizu VM, Gutierrez DJ, Fogelbach GA, Castellanos Olivares A, Vazquez Nava F, et al. Nasal budesonide plus zafirlukast vs nasal budesonide plus loratadine‐pseudoephedrine for controlling the symptoms of rhinitis and asthma. Revista Alergia Mexico 2005;52(2):90‐5. - PubMed
Berger 2006 {published data only}
    1. Berger WE, Milgrom H, Skoner DP, Tripp K, Parsey MV, Baumgartner RA. Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: A double‐blind, randomized, placebo‐ and active‐controlled trial. Current Medical Research & Opinion 2006;22(6):1217‐26. - PubMed
Bilancia 2000 {published data only}
    1. Bilancia R, Margiotta D, Balacco D. Low doses of budesonide (B) plus montelukast (M) versus high doses of budesonide in asthmatic patients. American Journal of Respiratory and Critical Care Medicine 2000;161(supp 3):A197.
Bilderback 2004 {published data only}
    1. Bilderback A, Krishnan JA, Riekert KA, Schiller K, Rand CS. Patterns of use for oral montelukast and inhaled fluticasone in a clinical trial [Abstract]. American Thoracic Society 100th International Conference 2004;B39:C18.
Bilderback 2005 {published data only}
    1. Bilderback A, Rand C, Krishnan J, Riekert K, Schiller K, Zieger RS, et al. Adherence with montelukast or fluticasone and outcomes in a 1‐year clinical trial in patients with mild persistent asthma [Abstract]. American Thoracic Society International Conference 2005;D97:Poster 521.
Bisgaard 1999 {published data only}
    1. Bisgaard H, Loland L, Anhoj J. NO in exhaled air of asthmatic children is reduced by the leukotriene receptor antagonist montelukast. American Journal of Respiratory & Critical Care Medicine 1999;160:1227‐31. - PubMed
Bisgaard 2000 {published data only}
    1. Bisgaard H, Nielsen KG. Bronchoprotection with a leukotriene receptor antagonist in asthmatic preschool children. American Journal of Respiratory & Critical Care Medicine 2000;162(1):187‐90. - PubMed
Bisgaard 2005 {published data only}
    1. Bisgaard H, Zielen S, Garcia‐Garcia ML, Johnston SL, Gilles L, Menten J, et al. Montelukast reduces asthma exacerbations in 2‐ to 5‐year‐old children with intermittent asthma. American Journal of Respiratory & Critical Care Medicine 2005;171(1):315‐22. - PubMed
Bjermer 2002 {published data only}
    1. Bjermer L, Greening A, Haahtela T, Bousquet J, Holgate ST, Picado C, et al. IMPACT study group. Addition of montelukast or salmeterol to fluticasone in patients with uncontrolled asthma: results of the IMPACT trial.. Chest. 2002:434.
Bjermer 2003 {published data only}
    1. Bjermer L, Bisgaard H, Bousquet J, Fabbri LM, Greening AP, Haahtela T, et al. Montelukast and fluticasone compared with salmeterol and fluticasone in protecting against asthma exacerbation in adults: one year, double blind, randomised, comparative trial. BMJ 2003;327(7420):891. - PMC - PubMed
Bjermer 2004 {published data only}
    1. Bjermer L, Kocevar VS, Zhang Q, Yin DD, Polos PG. Health care resource utilization following addition of montelukast or salmeterol in fluticasone in patients with inadequately controlled asthma (IMPACT trial) [Abstract]. European Respiratory Journal 2004;24(Suppl 48):127s.
Bleecker 2006 {published data only}
    1. Bleecker ER, Yancey SW, Baitinger LA, Edwards LD, Klotsman M, Anderson WH, et al. Salmeterol response is not affected by beta2‐adrenergic receptor genotype in subjects with persistent asthma. Journal of Allergy & Clinical Immunology 2006;118(4):809‐16. - PubMed
Borker 2005 {published data only}
    1. Borker R, Emmett A, Jhingran P, Rickard K, Dorinsky P. Determining economic feasibility of fluticasone propionate‐salmeterol vs montelukast in the treatment of persistent asthma using a net benefit approach and cost‐effectiveness acceptability curves. Annals of Allergy Asthma & Immunology 2005;95(2):181‐9. - PubMed
Bousquet 2005a {published data only}
    1. Bousquet J, Gaugris S, Kocevar VS, Zhang Q, Yin DD, Polos PG, et al. Increased risk of asthma attacks and emergency visits among asthma patients with allergic rhinitis: A subgroup analysis of the improving asthma control trial. Clinical & Experimental Allergy 2005;35(6):723‐7. - PubMed
Bousquet 2007 {published data only}
    1. Bousquet J, Rabe K, Humbert M, Chung KF, Berger W, Fox H, et al. Predicting and evaluating response to omalizumab in patients with severe allergic asthma. Respiratory Medicine 2007;101(7):1483‐92. - PubMed
Brannan 2001 {published data only}
    1. Brannan JD, Anderson SD, Gomes K, King GG, Chan HK, Seale JP. Fenofenadine decreases sensitivity to and montelukast improves recovery from inhaled manitol. American Journal of Respiratory & Critical Care Medicine 2001;163(6):1420‐5. - PubMed
Brocks 1996 {published data only}
    1. Brocks DR, Upward JW, Georgiou P, Stelman G, Doyle E, Allen E, et al. The single and multiple dose pharmacokinetics of pranlukast in healthy volunteers. European Journal of Clinical Pharmacology 1996;51:303‐8. - PubMed
Bronsky 1997 {published data only}
    1. Bronsky E, Grossman J, Nathan RA, Jong B. Pranlukast (Ultair) reduces symptoms of seasonal allergic rhinitis: results of the first US double‐blind, placebo controlled trial in 484 patients. SmithKline Beecham Pharmaceuticals 1997.
Brown 2005 {published data only}
    1. Brown ES, Stuard G, Liggin JDM, Hukovic N, Frol A, Dhanani N, et al. Effect of phenytoin on mood and declarative memory during prescription corticosteroid therapy. Biological Psychiatry 2005;57(5):543‐8. - PubMed
Brown 2007 {published data only}
    1. Brown ES, Frol AB, Khan DA, Larkin GL, Bret ME. Impact of levetiracetam on mood and cognition during prednisone therapy. European Psychiatry 2007;22(7):448‐52. - PubMed
Brown 2010 {published data only}
    1. Brown ES, Denniston D, Gabrielson B, Khan DA, Khanani S, Desai S. Randomized, double‐blind, placebo‐controlled trial of acetaminophen for preventing mood and memory effects of prednisone bursts. Allergy and Asthma Proceedings 2010;31(4):331‐6. - PubMed
Bruce 2002 {published data only}
    1. Bruce C, Palmqvist M, Sjöstrand M, Aronsson B, Arvidsson P, Lotvall J. Greater attenuation of the late asthmatic reaction by fluticasone propionate compared to montelukast. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A215.
Buchvald 2002 {published data only}
    1. Buchvald FF, Bisgaard H. Comparison of add‐on of leukotriene receptor antagonist vs. long‐acting beta 2‐agonist of FeNO in asthmatic children on regular inhaled budesonide. European Respiratory Journal 2002;20(Suppl 38):431s.
Buchvald 2002a {published data only}
    1. Buchvald FF, Bisgaard H. Comparison of add‐on of leukotriene receptor antagonist vs. long‐acting beta2‐agonist on FeNO in asthmatic children on regular inhaled budesonide [abstract]. European Respiratory Society Annual Congress. 2002:P2736.
Buchvald 2003 {published data only}
    1. Buchvald F, Bisgaard H. Comparisons of the complementary effect on exhaled nitric oxide of salmeterol vs montelukast in asthmatic children taking regular inhaled budesonide. Annals of Allergy Asthma & Immunology 2003;91(3):309‐13. - PubMed
Buckstein 2003 {published data only}
    1. Bukstein DA, Luskin AT, Bernstein A. "Real‐world" effectiveness of daily controller medicine in children with mild persistent asthma. Annals of Allergy Asthma & Immunology 2003;90(5):543‐9. - PubMed
Burgess 2007 {published data only}
    1. Burgess SW, Sly PD, Cooper DM, Devadason SG. Novel spacer device does not improve adherence in childhood asthma. Pediatric Pulmonology 2007;42(8):736‐9. - PubMed
Busse 1999 {published data only}
    1. Busse W, Nelson H, Wolfe J, Kalberg C, Yancey SW, Rickard KA. Comparison of inhaled salmeterol and oral zafirlukast in patients with asthma. Journal of Allergy & Clinical Immunology 1999;103:1075‐80. - PubMed
Buxton 2004 {published data only}
    1. Buxton MJ, Sullivan SD, Andersson LF, Lamm CJ, Liljas B, Busse WW, et al. Country‐specific cost‐effectiveness of early intervention with budesonide in mild asthma. European Respiratory Journal 2004;24(4):568‐74. - PubMed
Cakmak 2000 {published data only}
    1. Cakmak G, Demir T, Aydemir A, Serdaroglu E, Erginoz E, Donma O, et al. The effect of adding zafirlukast to budesonide treatment on total antoxydant capacity. European Respiratory Journal 2000;16(Supplement 31):457s.
Cakmak 2004 {published data only}
    1. Cakmak G, Demir T, Gemicioglu B, Aydemir A, Serdaroglu E, Donma O. The effects of add‐on zafirlukast treatment to budesonide on bronchial hyperresponsiveness and serum levels of eosinophilic cationic protein and total antioxidant capacity in asthmatic patients. Tohoku Journal of Experimental Medicine 2004;204(4):249‐56. - PubMed
Calhoun 1997 {published data only}
    1. Calhoun WJ, Weisberg SC, Faiferman I, Stober PW. Pranlukast (Ultair) is effective in improving asthma: results of a 12‐week, multicenter, dose‐range study. Journal of Allergy & Clinical Immunology 1997;99:S318, Abs 1305.
Calhoun 2001 {published data only}
    1. Calhoun WJ, Nelson HS, Nathan RA, Pepsin PJ, Kalberg C, Emmett A, et al. Comparison of fluticasone propionate‐salmeterol combination therapy and montelukast in patients who are symptomatic on short‐acting beta(2)‐agonists alone. American Journal of Respiratory & Critical Care Medicine 2001;164(5):759‐63. - PubMed
Calhoun 2004 {published data only}
    1. Calhoun W, Sutton L, Emmett A, Dorinsky P. Asthma control with fluticasone propionate/salmeterol 100/50µg Diskus(r) versus montelukast in patients previously receiving short‐acting beta2‐agonists [Abstract]. Journal of Allergy and Clinical Immunology 2004;113(Suppl 2):S117.
Camargo 2002 {published data only}
    1. Camargo CA, Smithline HA, Marie‐Pierre M, Green SA, Reiss TF. A randomized controlled trial of intravenous montelukast in acute asthma. American Journal of Respiratory and Critical Care Medicine. 2002. - PubMed
Camargo 2003 {published data only}
    1. Camargo CA Jr, Smithline HA, Malice MP, Green SA, Reiss TF. A randomized controlled trial of intravenous montelukast in acute asthma. American Journal of Respiratory & Critical Care Medicine 2003;167(4):528‐33. - PubMed
Canino 2008 {published data only}
    1. Canino G, Vila D, Normand SLT, Acosta‐Perez E, Ramirez R, Garcia P, et al. Reducing asthma health disparities in poor Puerto Rican children: The effectiveness of a culturally tailored family intervention. Journal of Allergy and Clinical Immunology 2008;121(3):665‐70. - PMC - PubMed
Capella 2001 {published data only}
    1. Capella GL, Frigerio E, Altomare G. A randomized trial of leukotriene receptor antagonist montelukast in moderate‐to‐severe atopic dermatitis of adults. European Journal of Dermatology 2001;11(3):209‐13. - PubMed
Ceylan 2004 {published data only}
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Choi 2003 {published data only}
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Chopra 2005 {published data only}
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Chung 2000 {published data only}
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Ciebiada 2009 {published data only}
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Claesson 1998 {published data only}
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    1. Currie GP, Lee DK, Dempsey OJ, Fowler SJ, Cowan LM, Lipworth BJ. A proof of concept study to evaluate putative benefits of montelukast in moderate persistent asthmatics. British Journal of Clinical Pharmacology 2003;55(6):609‐15. - PMC - PubMed
Currie 2003a {published data only}
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Currie 2003b {published data only}
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Cylly 2003 {published data only}
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Dahlén 2002 {published data only}
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Daikh 2003 {published data only}
    1. Daikh BE, Ryan CK, Schwartz RH. Montelukast reduces peripheral blood eosinophilia but not tissue eosinophilia or symptoms in a patient with eosinophilic gastroenteritis and esophageal stricture. Annals of Allergy, Asthma, & Immunology 2003;90(1):2327. - PubMed
Davies 2004 {published data only}
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Daviskas 2007 {published data only}
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Dekhuijzen 2006 {published data only}
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Delaronde 2005 {published data only}
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Dempsey 1999 {published data only}
    1. Dempsey OJ, Wilson AM, Sims EJ, Lipworth BJ. A comparison of once daily topical budesonide (BUD) and oral montelukast (MON) in seasonal allergic rhinitis (SAR) and asthma. European Respiratory Society. 1999. - PubMed
Dempsey 2000 {published data only}
    1. Dempsey OJ, Wilson AM, Sims EJ, Mistry C, Lipworth BJ. Additive bronchoprotective and bronchodilator effects with single doses of salmeterol and montelukast in asthmatic patients receiving inhaled corticosteroids. Chest 2000;117:950‐3. - PubMed
Dempsey 2000a {published data only}
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Dempsey 2002b {published data only}
    1. Dempsey OJ, Fowler SJ, Wilson A, Kennedy G, Lipworth BJ. Effects of adding either a leukotriene receptor antagonist or low‐dose theophylline to a low or medium dose of inhaled corticosteroid in patients with persistent asthma. Chest 2002;122(1):151‐9. - PubMed
Demuro‐Mercon 2001 {published data only}
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Dessanges 1999 {published data only}
    1. Dessanges JF, Prefaut C, Taytard A, Matran R, Naya I, Compagnon A, et al. The effect of zafirlukast on repetitive exercise‐induced bronchoconstriction: The possible role of leukotrienes in exercise‐induced refractoriness. Journal of Allergy & Clinical Immunology 1999;104(6):1155‐61. - PubMed
Deykin 2007 {published data only}
    1. Deykin A, Wechsler ME, Boushey HA, Chinchilli VM, Kunselman SJ, Craig TJ, et al. Combination therapy with a long‐acting beta‐agonist and a leukotriene antagonist in moderate asthma. American Journal of Respiratory & Critical Care Medicine 2007;175(3):228‐34. - PMC - PubMed
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Diamant 2009 {published data only}
    1. Diamant Z, Ulrik CS. Effect of add‐on montelukast to inhaled corticosteroids on excessive airway narrowing in adult asthmatics [Abstract]. American Thoracic Society International Conference. 2009:A2416.
Dicpinigaitis 2002 {published data only}
    1. Dicpinigaitis PV, Dobkin JB, Reichel J. Antitussive effect of the leukotriene receptor antagonist zafirlukast in subjects with cough‐variant asthma. Journal of Asthma 2002;39(4):291‐7. - PubMed
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Dockhorn 2000 {published data only}
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Dorinsky 2001 {published data only}
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Dorinsky 2002 {published data only}
    1. Dorinsky PM, Crim C, Yancey S, Edwards L, Rickard K. First line therapy with fluticasone propionate/salmeterol combination product provides superior asthma control versus montelukast or fluticasone propionate alone [Abstract]. Journal of Allergy Asthma and Immunolgy 2002;109(Suppl 1):Abstract No: 767.
Dorinsky 2004 {published data only}
    1. Dorinsky PM, Stauffer J, Waitkus‐Edwards K, Yancey S, Prillaman BA, Sutton L. "Stepping Down" from Fluticasone Propionate/Salmeerol 100/50mcg Diskus(R) Results in Loss of Asthma Control: Lack of Effect of Ethnic Origin [Abstract]. Chest 2004;126(Suppl 4):758S.
Edelman 2000 {published data only}
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Eliraz 2001 {published data only}
    1. Eliraz A, Raminez‐Rivera A, Ferranti P, et al. Similar efficacy following four weeks treatment of asthmatics with formoterol 12 mcg bid delivered by two different dry powder inhalers: differences in inhaler handling. International Journal of Clinical Practice 2001;55(3):164‐70. - PubMed
El Miedany 2006 {published data only}
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Ensom 2003 {published data only}
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Fagerson 2003 {published data only}
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Failla 2006 {published data only}
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Faul 2002 {published data only}
    1. Faul JL, Canfield JC, Gould MK, Wilson SR, Kischner WG. A randomized, double‐blind, placebo‐controlled, crossover study comparing the effects of inhaled fluticasone propionate (880 Micrograms per day) and montelukast (10 MG per day) on glucose control patients with diabetes and asthma. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A217.
Findlay 1992 {published data only}
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Fish 2001 {published data only}
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Galbreath 2008 {published data only}
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Ghiro 2001 {published data only}
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Green 2002a {published data only}
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Grossman 1997 {published data only}
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Guilbert 2004 {published data only}
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Gupta 2007 {published data only}
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Gylfors 2005 {published data only}
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Hassall 1998 {published data only}
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Havlucu 2005 {published data only}
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Hood 1999 {published data only}
    1. Hood PP, Cotter TP, Costello JF, Sampson AP. Effect of intravenous corticosteroid on ex vivo leukotriene generation by blood leucocytes of normal and asthmatic patients. Thorax 1999;54(12):1075‐82. - PMC - PubMed
Hothersall 2008 {published data only}
    1. Hothersall EJ, Chaudhuri R, McSharry C, Donnelly I, Lafferty J, McMahon AD, et al. Effects of atorvastatin added to inhaled corticosteroids on lung function and sputum cell counts in atopic asthma. Thorax 2008;63(12):1070‐5. - PubMed
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    1. Houghton CM, Langley SJ, Singh SD, Holden J, Monici Preti AP, Acerbi D, et al. Comparison of bronchoprotective and bronchodilator effects of a single dose of formoterol delivered by hydrofluoroalkane and chlorofluorocarbon aerosols and dry powder in a double blind, placebo‐controlled, crossover study. British Journal of Clinical Pharmacology 2004;58(4):359‐66. - PMC - PubMed
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    1. Howland III W, Segal A, Glass M, Minkwitz MC. 6‐week therapy with the oral leukotriene‐receptor antagonist, ICI 204,219, in the treatment of asthma. Journal of Allergy & Clinical Immunology 1994;93(1 Part 2):259, Abs. 581.
Hozawa 2009 {published data only}
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    1. Huang CJ, Wang CH, Lin HC, Yu CT, Shiao JR, Tan CG, et al. Zafirlukast improves pulmonary function in patients with moderate persistent asthma receiving regular inhaled steroids: a randomized control study [abstract]. American Thoracic Society 99th International Conference 2003;B036:Poster H80. - PubMed
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    1. Igde M, Anlar FY. The efficacy of montelukast monotherapy in moderate persistent asthmatic children. Iranian Journal of Allergy Asthma & Immunology 2009;8(3):169‐70. - PubMed
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    1. Ikeda K, Hyashi M, Obata H, Fujita H, Nakanishi T, Izumi T. Two weeks' observation of pranlukast (ONO‐1078), leukotriene receptor antagonist) by peak expiratory flow rate (PEFR) was enough to evaluate clinical efficacies in severe chronic adult asthmatics. American Thoracic Society. 1997:Abs C49.
Ilowite 2004 {published data only}
    1. Ilowite J, Webb R, Friedman B, Kerwin E, Bird SR, Hustad CM, et al. Addition of montelukast or salmeterol to fluticasone for protection against asthma attacks: a randomized, double‐blind, multicenter study. Annals of Allergy Asthma & Immunology 2004;92(6):641‐8. - PubMed
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Irvin 2007 {published data only}
    1. Irvin CG, Kaminsky DA, Anthonisen NR, Castro M, Hanania NA, Holbrook JT, et al. Clinical trial of low‐dose theophylline and montelukast in patients with poorly controlled asthma. American Journal of Respiratory & Critical Care Medicine 2007;175(3):235‐42. - PubMed
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Israel 1993 {published data only}
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    1. Jat GC, Mathew JL, Singh M. Treatment with 400 mug of inhaled budesonide vs 200 mug of inhaled budesonide and oral montelukast in children with moderate persistent asthma: Randomized controlled trial. Annals of Allergy Asthma & Immunology 2006;97(3):397‐401. - PubMed
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Jayaram 2005a {published data only}
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Johnston 2007 {published data only}
    1. Johnston NW, Mandhane PJ, Dai J, Duncan JM, Greene JM, Lambert K, et al. Attenuation of the September epidemic of asthma exacerbations in children: A randomized, controlled trial of montelukast added to usual therapy. Pediatrics 2007;120(3):e702‐e712. - PubMed
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Jonsson 2004 {published data only}
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Kalberg 1999 {published data only}
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Kanazawa 2004 {published data only}
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Kanniess 2002a {published and unpublished data}
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    1. Karaman O, Arli O, Uzuner N, Islekel H, Babayigit A, Olmez D, et al. The effectiveness of asthma therapy alternatives and evaluating the effectivity of asthma therapy by interleukin‐13 and interferon gamma levels in children. Allergy & Asthma Proceedings 2007;28(2):204‐9. - PubMed
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    1. Karpel JP, Nayak A, Lumry W, Craig TJ, Kerwin E, Fish JE, et al. Inhaled mometasone furoate reduces oral prednisone usage and improves lung function in severe persistent asthma. Respiratory Medicine 2007;101(3):628‐37. - PubMed
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    1. Katial RK, Oppenheimer JJ, Ostrom NK, Mosnaim GS, Yancey SW, Waitkus‐Edwards KR, et al. Adding montelukast to fluticasone propionate/salmeterol for control of asthma and seasonal allergic rhinitis. Allergy and Asthma Proceedings 2010;31(1):68‐75. - PubMed
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    1. Kemp JP, Glass M, Minkwitz MC. Onset of action of the leukotriene‐receptor antagonist, zafirlukast (Accolate), in patients with asthma. Journal of Allergy & Clinical Immunology 1995;95(1 Part 2):351, Abs. 844.
Kemp 1996 {published data only}
    1. Kemp JP. Zafirlukast, a selective leukotriene D4‐receptor antagonist: a new class of therapy for patients with asthma. Today's Therapeutic Trends 1996;14(2):89‐102.
Kemp 1998 {published data only}
    1. Kemp JP, Tinkelman D, Sublett J, Compton C, Georgiou P. Pranlukast (Ultair) pharmacokinetics in children consistent with that of adults. American Journal of Respiratory & Critical Care Medicine 1998;157(3):A411.
Kemp 1998a {published data only}
    1. Kemp JP, Dockhorn RJ, Shapiro GG, Nguyen HH, Reiss TF, Seidenberg BC, et al. Montelukast once daily inhibits exercise induced bronchoconstriction in 6‐14 year old children with asthma. The Journal of Pediatrics 1998;133(3):424‐28. - PubMed
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Ketchell 2002 {published data only}
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Kippelen 2010 {published data only}
    1. Kippelen P, Larsson J, Anderson SD, Brannan JD, Delin I, Dahlen B, et al. Acute effects of beclomethasone on hyperpnea‐induced bronchoconstriction. Medicine & Science in Sports & Exercise 2010;42(2):273‐80. - PubMed
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    1. Kips JC, Joos GF, Lepeleire I, Margolskee DJ, Buntinx A, Pauwels RA, et al. MK‐571, a potent antagonist of leukotriene D4‐induced bronchoconstriction in the human. American Review of Respiratory Disease 1991;144:617‐21. - PubMed
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    1. Knorr B, Nguycn HH, Seidenberg BC, Reiss TF, Montelukast Pediatric Study Group. Montelukast, a leukotriene receptor antagonist, provides additional clinical benefit in asthmatic children aged 6 to 14 years using inhaled corticosteroids. European Respiratory Society. 1999:P363.
Koenig 2004 {published data only}
    1. Koenig S, Waitkus‐Edwards K, Yancey S, Prillman B, Dorinsky P. Loss of asthma control when patients receiving fluticasone propionate/salmeterol 100/50µg Diskus are "stepped‐down" to fluticasone propionate , salmeterol or montelukast alone [Abstract]. Journal of Allergy and Clinical Immunology 2004;113(Suppl 2):S94.
Kohrogi 1997 {published data only}
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Kondo 2006 {published data only}
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Korenblat 1998 {published data only}
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Kuna 1997 {published data only}
    1. Kuna P, Malmstrom K, Dahlen SE, Nizankowska E, Kowalski M, Stevenson D, et al. Montelukast (MK‐0476), a cys‐LT1 receptor antagonist, improves asthma control in aspirin‐intolerant asthmatic patients. American Journal of Respiratory & Critical Care Medicine 1997;155(4):A975.
Kylstra 1998 {published data only}
    1. Kylstra JW, Sweitzer DE, Miller CJ, Bonuccelli CM. Zafirlukast (Accolate) in moderate asthma: patient‐reported outcomes and peripheral eosinophil data from a 13‐week trial. American Journal of Respiratory & Critical Care Medicine 1998;157(3):A410.
Laitinen 1995 {published data only}
    1. Laitinen LA, Zetterstrom O, Holgate ST, Binks SM, Whitney JG. Effects of Accolate (Zafirlukast; 20 mg bd) in permitting reduced therapy with inhaled steroids: a multicenter trial in patients with doses of inhaled steroid optimised between 800 and 2000 mcg per day. Allergy 1995;50 Suppl(26):320, Abs. P‐0710.
Leaker 2010 {published data only}
    1. Leaker BR, Singh D, Barnes PJ, Imrie M, Hughes R, O'Connor B. The Effect Of The Novel Phosphodiesterase‐4 Inhibitor MEM 1414 On The Allergen‐induced Responses In mild Asthma [Abstract]. American Journal of Respiratory and Critical Care Medicine 2010;181:A5613. - PMC - PubMed
Lee 2004 {published data only}
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Lee 2004a {published data only}
    1. Lee DK, Haggart K, Currie GP, Bates CE, Lipworth BJ. Effects of hydrofluoroalkane formulations of ciclesonide 400 microg once daily vs fluticasone 250 microg twice daily on methacholine hyper‐responsiveness in mild‐to‐moderate persistent asthma. British Journal of Clinical Pharmacology 2004;58(1):26‐33. - PMC - PubMed
Lee 2004b {published data only}
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Lee 2005 {published data only}
    1. Lee DK, Fardon TC, Bates CE, Haggart K, McFarlane LC, Lipworth BJ. Airway and systemic effects of hydrofluoroalkane formulations of high‐dose ciclesonide and fluticasone in moderate persistent asthma. Chest 2005;127(3):851‐60. - PubMed
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Leibman 2002 {published data only}
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Leibman 2002a {published data only}
    1. Leibman CW, Stanford R, Emmett A, Dorinsky PM, Rickard KA. Cost‐effectiveness of fluticasone propionate‐salmeterol combination versus fluticasone + montelukast in the treatment of persistent asthma. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):B4.
Leigh 2002 {published data only}
    1. Leigh R, Vethanayagam D, Yoshida M, Watson RM, Rerecich T, Inman MD, et al. Effects of montelukast and budesonide on airway responses and airway inflammation in asthma. American Journal of Respiratory and Critical Care Medicine 2002;166(9):1212‐7. - PubMed
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    1. Leigh R, Vethanayagam D, Yoshida M, Watson RM, Rererich T, Killian K, et al. Effects of montelukast and budesonide alone or in combination on allergen induced early and late asthmatic responses, and post‐allergen airway hyperresponsiveness [abstract]. American Journal of Respiratory and Critical Care Medicine 2002;165(8 Suppl):A216.
Lemanske 2010 {published data only}
    1. Lemanske RF Jr, Mauger DT, Sorkness CA, Jackson DJ, Boehmer SJ, Martinez FD, et al. Step‐up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. New England Journal of Medicine 2010;362(11):975‐85. - PMC - PubMed
Li 2001 {published data only}
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Liebke 2001 {published data only}
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    1. Lindemann J, Pampe ED, Peterkin JJ, Orozco‐Cronin P, Belofsky G, Stull D. Clinical study of the effects on asthma‐related QOL and asthma management of a medical food in adult asthma patients. Current Medical Research and Opinion 2009;25(12):2865‐75. - PubMed
Lipworth 1999 {published data only}
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Lofdahl 1999 {published data only}
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Lyseng‐Williamson 2003 {published data only}
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Marogna 2010 {published data only}
    1. Marogna M, Colombo F, Spadolini I, Massolo A, Berra D, Zanon P, et al. Randomized open comparison of montelukast and sublingual immunotherapy as add‐on treatment in moderate persistent asthma due to birch pollen. Journal of Investigational Allergology & Clinical Immunology 2010;20(2):146‐52. - PubMed
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Maspero 2008a {published data only}
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McCarthy 2003 {published data only}
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    1. Ponce Castro H, Rodríguez Espino S, Rodríguez Orozco AR. Administration of budesonide (inhaled steroid) to children to control intermittent asthma. Revista Alergia Mexico 2009;26(1):9‐12. - PubMed
Price 1999 {unpublished data only}
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Price 2002 {published data only}
    1. Price DB, Hernandez D, Magyar P, Fiterman J, Beeh KM, James IG, et al. Adding montelukast is at least as efficacious as doubling the budesonide dose in persistent asthma: Results of the compact study. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl8):A216.
Price 2003 {published data only}
    1. Price DB, Hernandez D, Magyar P, Fiterman J, Beeh KM, James IG, et al. Randomised controlled trial of montelukast plus inhaled budesonide versus double dose inhaled budesonide in adult patients with asthma. Thorax 2003;58(3):211‐6. - PMC - PubMed
Price 2004 {published data only}
    1. Price DB, Zhang Q, Kocevar VS, Polos PG, Yin DD. Healthcare resource use the following addition of montelukast to budesonide compared to doubling the dose of budesonide in patients with inadequately controlled asthma (COMPACT trial) [Abstract]. European Respiratory Journal 2004;24(Suppl 48):126s.
Price 2006 {published data only}
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Pullerits 1999 {published data only}
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Pullerits 2001 {published data only}
    1. Pullerits T, Praks L, Baker R, Ani R, Lotvall J. Comparison of nasal fluticasone propionate, montelukast, and combined montelukast+loratadine in allergic rhinitis [abstract]. American Journal of Respiratory and Critical Care Medicine 2001;163(5 Suppl):A193.
Pullerits 2002 {published data only}
    1. Pullerits T, Praks L, Ristioja V, Lotvall J. Comparison of a nasal glucocorticoid, antileukotriene, and a combination of antileukotriene and antihistamine in the treatment of seasonal allergic rhinitis. Journal of Allergy & Clinical Immunology 2002;109(6):949‐55. - PubMed
Qaqundah 2006 {published data only}
    1. Qaqundah PY, Sugerman RW, Ceruti E, Maspero JF, Kleha JF, Scott CA, et al. Efficacy and safety of fluticasone propionate hydrofluoroalkane inhalation aerosol in pre‐school‐age children with asthma: A randomized, double‐blind, placebo‐controlled study. Journal of Pediatrics 2006;149(5):663‐70. - PubMed
Rachelefsky 1997 {published data only}
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Ragab 2001 {published data only}
    1. Ragab S, Parikh A, Darby YC, Scadding GK. An open audit of montelukast, a leukotriene receptor antagonist, in nasal polyposis associated with asthma. Clinical & Experimental Allergy 2001;31(9):1385‐91. - PubMed
Ramsay 1997 {published data only}
    1. Ramsay CF, Kan CI, Nieman RB, Wang J, Krieken JHJM, Willems LNA, et al. The effects of oral pranlukast on airway immunopathology and clinical parameters in patients with asthma. American Thoracic Society. 1997:Abs C21.
Ramsay 1998 {published data only}
    1. Ramsay CF, Kan CI, Sterk PJ, Barnes NC. Pranlukast improves spirometry and bronchial hyperresponsiveness (BHR) in patients with mild asthma. American Journal of Respiratory & Critical Care Medicine 1998;157(3):A411.
Rand 2004 {published data only}
    1. Rand CS, Bilderbank A, Krishnan J, Riekert K, Schiller K, MIAMI Study Research Group. Adherence with oral montelukast sodium or fluticasone propionate in a clinical trial [Abstract]. Journal of Allergy and Clinical Immunology 2004;113(Suppl 2):s157.
Ratner 2003 {published data only}
    1. Ratner PH, Howland WC, Arastu R, Philpot EE, Klein KC, Baidoo CA, et al. Fluticasone propionate aqueous nasal spray provided significantly greater improvement in daytime and nighttime nasal symptoms of seasonal allergic rhinitis compared with montelukast.[comment]. Annals of Allergy Asthma & Immunology 2003;90(5):536‐42. - PubMed
Reiss 1996 {published data only}
    1. Reiss TF, Altman LC, Chervinsky P, Bewtra A, Stricker WE, Noonan GP, et al. Effects of montelukast (MK‐0476), a new potent cysteinyl leukotriene (LTD4) receptor antagonist, in patients with chronic asthma. Journal of Allergy & Clinical Immunology 1996;98:528‐34. - PubMed
Reiss 1997 {unpublished data only}
    1. Reiss TF, White R, Noonan G, Korenblat P, Hess J, Shingo S. Montelukast (MK‐0476) a cys LT1 receptor antagonist improves the signs and symptoms of asthma over one year of treatment. European Respiratory Journal 1997;10 Suppl(25):437.
Reiss 1997b {published data only}
    1. Reiss TF, et al. Montelukast improves asthma outcomes over a 3‐month treatment period. American Thoracic Society. 1997.
Reiss 1997c {published data only}
    1. Reiss TF, Sorkness CA, Stricker W, Botto A, Busse WW, Kundu S, et al. Effects of montelukast (MK‐0476), a potent cysteinyl leukotriene receptor antagonist, on bronchodilation in asthmatic subjects treated with and without inhaled corticosteroids. Thorax 1997;52(1):45‐8. - PMC - PubMed
Reiss 1998 {published data only}
    1. Reiss TF, Chervinsky P, Dockhorn RJ, Shingo S, Seidenberg B, Edwards TB. Montelukast, a once‐daily leukotriene receptor antagonist, in the treatment of chronic asthma. Archives of Internal Medicine 1998;158:1213‐20. - PubMed
Reiss 2008 {published data only}
    1. Reiss TF, Lu S, Liu N. A randomized study comparing concomitant montelukast and loratadine with montelukast, loratadine and beclomethasone in patients with chronic asthma [Abstract]. Chest 2008;134(4):93001s. - PubMed
Riccioni 2001a {published data only}
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Riccioni 2002 {published data only}
    1. Riccioni G, Santilli F, Guagnano MT, Vecchia RD. Montelukast versus budesonide on quality of life in asthmatic subjects [abstract]. European Respiratory Society Annual Congress. 2002:P757.
Riccioni 2003a {published data only}
    1. Riccioni G, D'Orazio N, Castronuovo M, Menna V, Lambo MS, Stefano F, et al. Dosage tapering of inhalatory budesonide in subjects with mild to moderate persistent asthma treated with montelukast [Abstract]. European Respiratory Journal 2003;22(Suppl 45):Abstract No: P713.
Riccioni 2005 {published data only}
    1. Riccioni G, Della Vecchia R, Castronuovo M, Ilio C, D'Orazio N. Tapering dose of inhaled budesonide in subjects with mild‐to‐moderate persistent asthma treated with montelukast: A 16‐week single‐blind randomized study. Annals of Clinical & Laboratory Science 2005;35(3):285‐9. - PubMed
Rickard 1999 {published data only}
    1. Rickard KA, Yancey S, Emmet AH, Kalberg CJ. Salmeterol compared to zafirlukast when added to inhaled corticosteroid therapy in patients with persistent asthma. European Respiratory Society. 1999:P839.
Rickard 2001 {published data only}
    1. Rickard K, Dorinsky PM, Knobil K, Pepsin P, Akveld ML. The salmeterol/fluticasone propionate combination 50/100µg bid is more effective than oral montelukast 10mg od as a first line therapy in mild and moderate asthmatics. European Respiratory Journal 2001;18(Suppl 33):262s.
Ringdal 1997 {published data only}
    1. Ringdal N, Whitney JG, Summerton L. Problems with inhaler technique and patient preference for oral therapy tablet zafirlukast vs. inhaled beclomethasone. European Respiratory Journal 1997;10 Suppl(25):437, abs P2806.
Ringdal 2003 {published data only}
    1. Ringdal N, Eliraz A, Pruzinec R, Weber HH, Mulder PG, Akveld M, et al. The salmeterol/fluticasone combination is more effective than fluticasone plus oral montelukast in asthma. Respiratory Medicine 2003;97(3):234‐41. - PubMed
Robinson 2001 {published data only}
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Rosenhall 2003 {published data only}
    1. Rosenhall L, Elvstrand A, Tilling B, Vinge I, Jemsby P, Stahl E, et al. One‐year safety and efficacy of budesonide/formoterol in a single inhaler (Symbicort Turbuhaler ) for the treatment of asthma. Respiratory Medicine 2003;97(6):702‐8. - PubMed
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Ruggins 2003 {published data only}
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Sahn 1997 {published data only}
    1. Sahn SA, Galant S, Murray J, Bronsky E, Spector S, Faiferman I, et al. Pranlukast (Ultair) improves FEV in patients with asthma: results of a 12‐week multicenter study vs. nedocromil. American Thoracic Society. 1997:Abs C49.
Sano 2006 {published data only}
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    1. Schneider A, Wensing M, Biessecker K, Quinzler R, Kaufmann‐Kolle P, Szecsenyi J. Impact of quality circles for improvement of asthma care: Results of a randomized controlled trial. Journal of Evaluation in Clinical Practice 2008;14(2):185‐90. - PMC - PubMed
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    1. Schuh S, Willan AR, Stephens D, Dick PT, Coates A. Can montelukast shorten prednisolone therapy in children with mild to moderate acute asthma? A randomized controlled trial. Journal of Pediatrics 2009;155(6):795‐800. - PubMed
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    1. Schwartz HJ, Petty T, Reed R, Dube LM, Swanson LJ, Zileuton Study Group. The comparative effects of zileuton, a 5‐lipoxygenase inhibitor, vs. theophylline in patients with moderate asthma: results from a 13‐week multicenter trial. ALA/ATS. 1995.
SD‐004‐0216 {published data only}
    1. Oxis Turbuhaler® (formoterol), Accolate® (zafirlukast) or placebo as add on treatment to Pulmicort Turbuhaler® (budesonide) in asthmatic patients on inhaled steroids. AstraZeneca Clinical Trials 2000.
Shah 2003 {published data only}
    1. Shah AR. Which Is More Steroid Sparing in Persistent Bronchial Asthma: Montelukast Or Theophylline? [Abstract]. Chest 2003;124(4):107.
Shah 2004 {published data only}
    1. Shah A, Solanki R, Shah K. Effect of add on therapy compared with doubling steroid inhalation in bronchial asthma [Abstract]. Thorax 2004;59(Suppl 2):ii70.
Shah 2006 {published data only}
    1. Shah AR, Sharples LD, Solanki RN, Shah KV. Double‐blind, randomised, controlled trial assessing controller medications in asthma. Respiration 2006;73(4):449‐56. - PubMed
Sheth 2002 {published data only}
    1. Sheth K, Borker R, Emmett A, Rickard K, Dorinsky P. Cost‐effectiveness comparison of salmeterol/fluticasone propionate versus montelukast in the treatment of adults with persistent asthma.. Pharmacoeconomics 2002;20(13):909‐18. - PubMed
Shimoda 2005 {published data only}
    1. Shimoda T, Kishikawa R, Shoji S, Nishima S. The efficacy of anti‐inflammatory treatment in mild intermittent bronchial asthma [Abstract]. Journal of Allergy & Clinical Immunology 2005;115(Suppl 2):S1.
Shingo 2001 {unpublished data only}
    1. Shingo S, Zhang J, Noonan N, Reiss TF, Leff JA. A standardized composite clinical score allows safe tapering of inhaled corticosteroids in an asthma clinical trial.. Unpublished data (Personal Communication:Theodore Reiss June 2001) 2001.
Shoji 1999 {published data only}
    1. Shoji T, Yoshida S, Sakamoto H, Hasegawa H, Nakagawa H, Amayasu H. Anti‐inflammatory effect of roxithromycin in patients with aspirin‐intolerant asthma. Clinical & Experimental Allergy 1999;9(7):950‐6. - PubMed
Simons 2001 {published data only}
    1. Simons FER, Villa JR, Lee BW, Teper AM, Lyttle B, Aristizabal G, et al. Montelukast added to budesonide in children with persistent asthma: a randomised, double‐blind, crossover study. Journal of Pediatrics 2001;138(5):694‐8. - PubMed
Simpson 2004 {published data only}
    1. Simpson MD, Burton DL, Burton MA, Gissing PM, Bowman SL. Pharmaceutical Care: Impact on Asthma Medication Use. Journal of Pharmacy Practice & Research 2004;34(1):26‐9.
Sims 2003 {published data only}
    1. Sims EJ, Jackson CM, Lipworth BJ. Add‐on therapy with montelukast or formoterol in patients with the glycine‐16 beta2‐receptor genotype. British Journal of Clinical Pharmacology 2003;56(1):104‐111. - PMC - PubMed
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    1. Sims E, Freeman D, Kemp L, Musgrave S, Juniper L, Gilbert R, et al. Should guidelines be revised for add on therapy in asthma? A 2 year randomized pragmatic equivalence trail of leukotriene antagonist (LTRAs) and long acting beta agonists (LABAs) with inhaled corticosteroids (ICS) in primary care [Abstract]. European Respiratory Society Annual Congress. 2008:E233.
Smith 1993 {published data only}
    1. Smith LJ, Glass M, Minkwitz MC. Inhibition of leukotriene D4‐induced bronchoconstriction in subjects with asthma: a concentration‐effect study of ICI 204,219. Clinical Pharmacology & Therapeutics 1993;54(4):430‐6. - PubMed
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    1. Smith LJ, Hanby LA, Simonson MS, Simonson SG. Effect of zafirlukast on leukotriene D4 (LTD4) ‐ induced bronchoconstriction in asthmatic patients receiving inhaled corticosteroids [abstract]. European Respiratory Journal 1997;10(Suppl 25):437S.
Smith 1998 {published data only}
    1. Smith LJ, Hanby LA, Lavins BJ, Simonson SG. A single dose of zafirlukast reduces LTD4‐induced bronchoconstriction in patients on maintenance inhaled corticosteroid therapy. Annals of Allergy, Asthma, & Immunology 1998;81:43‐9. - PubMed
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    1. Smugar SS, Fogel R, Aristizabal G, Rosario N, Loeys T, Gaile S, et al. Effect of montelukast or salmeterol added to inhaled fluticasone on response to albuterol in children with exercise‐induced bronchoconstriction [Abstract]. European Respiratory Society Annual Congress. 2009:P1221.
Smugar 2009a {published data only}
    1. Smugar SS, Fogel R, Rosario N, Aristizabal G, Loeys T, Gaile S, et al. Attenuation of exercise‐induced bronchoconstriction with montelukast or salmeterol added to inhaled fluticasone in children [Abstract]. European Respiratory Society Annual Congress. 2009:P1217.
Spahn 1996a {published data only}
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Spector 1992 {published data only}
    1. Spector SL, Glass M, Minkwitz MC, ICI Asthma Trial Group. The effect of six weeks of therapy with oral doses of ICI 204,219 in asthmatics. American Review of Respiratory Disease 1992;145(4):A16.
Spector 1994 {published data only}
    1. Spector SL, Smith LJ, Glass M. Effects of 6 weeks of therapy with oral doses of ICI 204,219, a leukotriene D4 antagonist, in subjects with bronchial asthma. American Journal of Respiratory & Critical Care Medicine 1994;150:618‐23. - PubMed
Spector 1995 {published data only}
    1. Spector S, Miller CJ, Glass M. 13‐week dose‐response study with Accolate (zafirlukast) in patients with mild to moderate asthma. American Journal of Respiratory & Critical Care Medicine 1995;151(4):A379.
Spector 1996 {published data only}
    1. Spector SL. Management of asthma with zafirlukast. Drugs 1996;52 Suppl(6):36‐46. - PubMed
Stanford 2002 {published data only}
    1. Stanford RH, Borker R, Dorinsky P, Pepsin P, Kalberg C, Emmett A, et al. The cost and efficacy of fluticasone propionate/salmeterol combination versus montelukast in the treatment of adults with persistent asthma. Chest. 2002:P422.
Stensrud 2006 {published data only}
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Stevenson 2005 {published data only}
    1. Stevenson DD, Mehra PK, White AA, Gupta S, Woessner KM, Simon RA. Failure of tacrolimus to prevent aspirin‐induced respiratory reactions in patients with aspirin‐exacerbated respiratory disease. Journal of Allergy & Clinical Immunology 2005;116(4):755‐60. - PubMed
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    1. Sthoeger ZM, Eliraz A, Asher I, Berkman N, Elbirt D. The beneficial effects of Xolair (Omalizumab) as add‐on therapy in patients with severe persistent asthma who are inadequately controlled despite best available treatment (GINA 2002 step IV ‐ The Israeli arm of the INNOVATE study). Israel Medical Association Journal 2007;9(6):472‐5. - PubMed
Storms 2001 {published data only}
    1. Storms W, Michele TM, Knorr B, Noonan G, Shapiro G, Zhang J, et al. Clinical safety and tolerability of montelukast, a leukotriene receptor antagonist, in controlled clinical trials in patients aged > or = 6 years. Clinical & Experimental Allergy 2001;31(1):77‐87. - PubMed
Storms 2004 {published data only}
    1. Storms W, Chervinsky P, Ghannam AF, Bird S, Hustad CM, Edelman JM, et al. A comparison of the effects of oral montelukast and inhaled salmeterol on response to rescue bronchodilation after challenge. Respiratory Medicine 2004;98(11):1051‐62. - PubMed
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Strunk 2003 {published data only}
    1. Strunk RC, Szefler SJ, Phillips BR, Zeiger RS, Chinchilli VM, Larsen G, et al. Relationship of exhaled nitric oxide to clinical and inflammatory markers of persistent asthma in children. Journal of Allergy & Clinical Immunology 2003;112(5):883‐92. - PubMed
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Suissa 1997 {published data only}
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Sutherland 2010 {published data only}
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Suzuki 1997 {published data only}
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Svensson 1994 {published data only}
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Swern 2008 {published data only}
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Swernson 2003 {published data only}
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Tamaoki 1997 {published data only}
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Teper 2009 {published data only}
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Terzano 2001 {published data only}
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Thoma 2002 {published data only}
    1. Thoma S. Anti‐inflammatory effect of montelukast on corticosteroid‐dependent children with asthma [Dissertation] [[Reduktion der bronchialen Inflammation bei mildem bis mittelschwerem Asthma bronchiale im Kindesalter unter Additivtherapie mit Montelukast und inhalativem Budesonid]]. Universitat Freiburg 2002.
Todi 2010 {published data only}
    1. Todi VK, Lodha R, Kabra SK. Effect of addition of single dose of oral montelukast to standard treatment in acute moderate to severe asthma in children between 5 and 15 years of age: A randomised, double‐blind, placebo controlled trial. Archives of Disease in Childhood 2010;95(7):540‐3. - PubMed
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Tohda 2002 {published and unpublished data}
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Tomari 2001 {published data only}
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Townley 1995 {published data only}
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Trofor 2002 {published data only}
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Tsuchida 2005 {published data only}
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    1. Tug T, Godekmerdan A, Sari N, Karatas F, Erdem ES. Effects of supportive treatment such as antioxidant or leukotriene receptor antagonist drugs on inflammatory and respiratory parameters in asthma patients. Clinical Pharmacology & Therapeutics 2007;81(3):371‐6. - PubMed
Tukiainen 2002 {published data only}
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Ulrik 2009 {published data only}
    1. Ulrik CS, Diamant Z. Effect of add‐on montelukast to inhaled corticosteroids on excessive airway narrowing in adult asthmatics [Abstract]. European Respiratory Society Annual Congress. 2009:P1962.
Ulrik 2009a {published data only}
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Ulrik 2010 {published data only}
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