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Meta-Analysis
. 2012 Jul 11;2012(7):CD002991.
doi: 10.1002/14651858.CD002991.pub3.

Inhaled corticosteroids for stable chronic obstructive pulmonary disease

Ian A Yang  1 , Melissa S Clarke, Esther H A Sim, Kwun M Fong
Affiliations
Meta-Analysis

Inhaled corticosteroids for stable chronic obstructive pulmonary disease

Ian A Yang et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: The role of inhaled corticosteroids (ICS) in chronic obstructive pulmonary disease (COPD) has been the subject of much controversy. Major international guidelines recommend selective use of ICS. Recently published meta-analyses have reported conflicting findings on the effects of inhaled steroid therapy in COPD.

Objectives: To determine the efficacy and safety of inhaled corticosteroids in stable patients with COPD, in terms of objective and subjective outcomes.

Search methods: A pre-defined search strategy was used to search the Cochrane Airways Group Specialised Register for relevant literature. Searches are current as of July 2011.

Selection criteria: We included randomised trials comparing any dose of any type of inhaled steroid with a placebo control in patients with COPD. Acute bronchodilator reversibility to short-term beta(2)-agonists and bronchial hyper-responsiveness were not exclusion criteria. The a priori primary outcome was change in lung function. We also analysed data on mortality, exacerbations, quality of life and symptoms, rescue bronchodilator use, exercise capacity, biomarkers and safety.

Data collection and analysis: Two review authors independently assessed trial quality and extracted data. We contacted study authors for additional information. We collected adverse effects information from the trials.

Main results: Fifty-five primary studies with 16,154 participants met the inclusion criteria. Long-term use of ICS (more than six months) did not consistently reduce the rate of decline in forced expiratory volume in one second (FEV(1)) in COPD patients (generic inverse variance analysis: mean difference (MD) 5.80 mL/year with ICS over placebo, 95% confidence interval (CI) -0.28 to 11.88, 2333 participants; pooled means analysis: 6.88 mL/year, 95% CI 1.80 to 11.96, 4823 participants), although one major trial demonstrated a statistically significant difference. There was no statistically significant effect on mortality in COPD patients (odds ratio (OR) 0.98, 95% CI 0.83 to 1.16, 8390 participants). Long-term use of ICS reduced the mean rate of exacerbations in those studies where pooling of data was possible (generic inverse variance analysis: MD -0.26 exacerbations per patient per year, 95% CI -0.37 to -0.14, 2586 participants; pooled means analysis: MD -0.19 exacerbations per patient per year, 95% CI -0.30 to -0.08, 2253 participants). ICS slowed the rate of decline in quality of life, as measured by the St George's Respiratory Questionnaire (MD -1.22 units/year, 95% CI -1.83 to -0.60, 2507 participants). Response to ICS was not predicted by oral steroid response, bronchodilator reversibility or bronchial hyper-responsiveness in COPD patients. There was an increased risk of oropharyngeal candidiasis (OR 2.65, 95% CI 2.03 to 3.46, 5586 participants) and hoarseness. In the long-term studies, the rate of pneumonia was increased in the ICS group compared to placebo, in studies that reported pneumonia as an adverse event (OR 1.56, 95% CI 1.30 to 1.86, 6235 participants). The long-term studies that measured bone effects generally showed no major effect on fractures and bone mineral density over three years.

Authors' conclusions: Patients and clinicians should balance the potential benefits of inhaled steroids in COPD (reduced rate of exacerbations, reduced rate of decline in quality of life and possibly reduced rate of decline in FEV(1)) against the potential side effects (oropharyngeal candidiasis and hoarseness, and risk of pneumonia).

PubMed Disclaimer

Conflict of interest statement

Ian Yang, Kwun Fong, Melissa Clarke, Esther Sim: none declared.

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 rate of decline of post‐bronchodilator FEV1 (mL/yr), using generic inverse variance analysis
3
3
Forest plot of rate of decline in post‐bronchodilator FEV1 (mL/yr), using pooled means analysis
4
4
Forest plot of mortality in long‐term studies
5
5
Forest plot of exacerbations per patient per year, using generic inverse variance analysis
6
6
Forest plot of rate of exacerbations per patient per year, using pooled means analysis
1.1
1.1. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 1 Post‐bronchodilator FEV1 ‐ Rate of decline.
1.2
1.2. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 2 Change in post‐bronchodilator FEV1 (mL/yr).
1.3
1.3. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 3 FEV1 (% change from baseline).
1.4
1.4. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 4 Total number of deaths.
1.5
1.5. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 5 Exacerbation rate.
1.6
1.6. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 6 Exacerbation rate (no. per patient per yr).
1.7
1.7. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 7 Exacerbation rate ‐ stratified by analysis approach.
1.8
1.8. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 8 No. of patients with at least one exacerbation.
1.9
1.9. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 9 Change in SGRQ total score (units/yr).
1.10
1.10. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 10 Mean change in SGRQ ‐ total scores.
1.11
1.11. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 11 Total SGRQ score (units).
1.12
1.12. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 12 Cough score.
1.13
1.13. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 13 Breathlessness score.
1.14
1.14. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 14 Throat irritation (no. of patients).
1.15
1.15. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 15 Oropharyngeal candidiasis (no. of patients).
1.16
1.16. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 16 Hoarseness or dysphonia (no. of patients).
1.17
1.17. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 17 Bruising (no. of patients).
1.18
1.18. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 18 Vertebral fractures (no. of patients).
1.19
1.19. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 19 Cataracts (no. of patients).
1.20
1.20. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 20 No. of patients with serum cortisol below normal range at any time.
1.21
1.21. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 21 Any fractures (no. of patients).
1.22
1.22. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 22 Sputum production score.
1.23
1.23. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 23 Sputum colour score.
1.24
1.24. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 24 No. of patients with change from within to below normal for serum cortisol.
1.25
1.25. Analysis
Comparison 1 ICS versus placebo, parallel‐group studies, greater than 6 months (all doses), Outcome 25 Pneumonia.
2.1
2.1. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 1 Change in pre‐bronchodilator FEV1 compared with baseline.
2.2
2.2. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 2 Change in post bronchodilator FEV1 compared to baseline (L).
2.3
2.3. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 3 Morning PEFR (L/min).
2.4
2.4. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 4 Post‐bronchodilator FEV1 (change from baseline).
2.5
2.5. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 5 Change in pre‐bronchodilator FEV1 compared with baseline.
2.6
2.6. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 6 PEF (change scores).
2.7
2.7. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 7 FVC (change from baseline).
2.8
2.8. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 8 Total number of deaths.
2.9
2.9. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 9 No. of patients with at least one exacerbation.
2.10
2.10. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 10 6‐minute walk (change scores).
2.11
2.11. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 11 Change in 6‐minute walk distance from baseline (m).
2.12
2.12. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 12 Change from baseline in dyspnoea on CRQ (units).
2.13
2.13. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 13 Change from baseline in emotion on CRQ (units).
2.14
2.14. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 14 Change from baseline in fatigue on CRQ.
2.15
2.15. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 15 Change from baseline in mastery on CRQ (units).
2.16
2.16. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 16 Rescue beta‐agonist use (puffs/day).
2.17
2.17. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 17 Throat irritation (no. of patients).
2.18
2.18. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 18 Oropharyngeal candidiasis (no. of patients).
2.19
2.19. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 19 Hoarseness or dysphonia (no. of patients).
2.20
2.20. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 20 Pneumonia (no. of patients).
2.21
2.21. Analysis
Comparison 2 ICS versus placebo, parallel‐group studies, greater than 2 months to 6 months (all doses), Outcome 21 No. of patients with serum cortisol below normal range at any time.
3.1
3.1. Analysis
Comparison 3 ICS versus placebo, parallel‐group studies, 2 months or less (all doses), Outcome 1 Change in FEV1 compared to baseline (% increase).
3.2
3.2. Analysis
Comparison 3 ICS versus placebo, parallel‐group studies, 2 months or less (all doses), Outcome 2 Change in FVC compared to baseline (% increase).
3.3
3.3. Analysis
Comparison 3 ICS versus placebo, parallel‐group studies, 2 months or less (all doses), Outcome 3 Change in MMEFR compared to baseline (% increase).
3.4
3.4. Analysis
Comparison 3 ICS versus placebo, parallel‐group studies, 2 months or less (all doses), Outcome 4 Morning PEFR (L/min).
3.5
3.5. Analysis
Comparison 3 ICS versus placebo, parallel‐group studies, 2 months or less (all doses), Outcome 5 Evening PEFR (L/min).
3.6
3.6. Analysis
Comparison 3 ICS versus placebo, parallel‐group studies, 2 months or less (all doses), Outcome 6 Change in PEFR compared to baseline (% increase).
3.7
3.7. Analysis
Comparison 3 ICS versus placebo, parallel‐group studies, 2 months or less (all doses), Outcome 7 No. of patients with at least one exacerbation.
3.8
3.8. Analysis
Comparison 3 ICS versus placebo, parallel‐group studies, 2 months or less (all doses), Outcome 8 Rescue beta‐agonist use (puffs/day).
3.9
3.9. Analysis
Comparison 3 ICS versus placebo, parallel‐group studies, 2 months or less (all doses), Outcome 9 Oropharyngeal candidiasis (no. of patients).
4.1
4.1. Analysis
Comparison 4 ICS versus placebo, cross‐over studies, 2 months or less (all doses), Outcome 1 FEV1 (L).
4.2
4.2. Analysis
Comparison 4 ICS versus placebo, cross‐over studies, 2 months or less (all doses), Outcome 2 Daily PEFR (L/min).
4.3
4.3. Analysis
Comparison 4 ICS versus placebo, cross‐over studies, 2 months or less (all doses), Outcome 3 FEV1 % predicted.
4.4
4.4. Analysis
Comparison 4 ICS versus placebo, cross‐over studies, 2 months or less (all doses), Outcome 4 Rescue beta‐agonist use (puffs/day).
4.5
4.5. Analysis
Comparison 4 ICS versus placebo, cross‐over studies, 2 months or less (all doses), Outcome 5 Change in post‐bronchodilator FEV1.
5.1
5.1. Analysis
Comparison 5 ICS versus placebo, studies of COPD with BHR, greater than 2 months to 6 months (all doses), Outcome 1 Salbutamol rescue doses (per month).
5.2
5.2. Analysis
Comparison 5 ICS versus placebo, studies of COPD with BHR, greater than 2 months to 6 months (all doses), Outcome 2 Ipratropium rescue doses (per month).
5.3
5.3. Analysis
Comparison 5 ICS versus placebo, studies of COPD with BHR, greater than 2 months to 6 months (all doses), Outcome 3 Serum cortisol at 6 months (nM/L).
6.1
6.1. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 1 Change in pre‐bronchodilator FEV1 compared to baseline (L).
6.2
6.2. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 2 Change in pre‐bronchodilator VC compared to baseline (L).
6.3
6.3. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 3 Change in FEV1 before terbutaline as % baseline.
6.4
6.4. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 4 Change in FEV1 after terbutaline as % baseline.
6.5
6.5. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 5 Change in log10 PC20 histamine.
6.6
6.6. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 6 Change in log10 citric acid threshold.
6.7
6.7. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 7 Change in morning peak expiratory flow rate (L/min).
6.8
6.8. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 8 Change in evening peak expiratory flow rate (L/min).
6.9
6.9. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 9 Change in dyspnoea score.
6.10
6.10. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 10 Change in cough score.
6.11
6.11. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 11 Change in sputum score.
6.12
6.12. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 12 Change in rescue bronchodilator usage (puffs/day).
6.13
6.13. Analysis
Comparison 6 ICS versus placebo, studies of COPD with BHR, greater than 6 months (all doses), Outcome 13 Change in post‐bronchodilator FEV1 (mL/yr).
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Calverley 2003b {published data only}
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Calverley 2003c {unpublished data only}
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Calverley 2007 {unpublished data only}
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Calverley 2008 {published data only}
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Culpitt 1999 {published data only}
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Derenne 1995 {published data only}
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Ferreira 2001 {published data only}
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Ferreira 2003 {unpublished data only}
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GSK 2005 (FCO30002) {unpublished data only}
    1. FCO30002. A multicentre, randomised, placebo‐controlled, double‐blind comparison with 3 parallel groups to investigate the efficacy and safety of inhaled glucocorticoid fluticasone (500 μg bd via Diskus™) vs. oral glucocorticoid therapy vs. placebo in subjects with chronic obstructive airway disease (COPD) under therapy with Salmeterol (50 μg bd). GlaxoSmithKline Clinical Trial Register 2005.
GSK 2005 (FLTA3025) {unpublished data only}
    1. FLTA3025. A randomized, double‐blind, parallel‐group, comparative trial of inhaled fluticasone propionate 250mcg BID, 500mcg BID, and placebo BID via the DISKUS in subjects with chronic obstructive pulmonary disease (COPD). GlaxoSmithKline Clinical Trial Register 2005.
Guenette 2011 {published data only}
    1. Guenette JA, Raghavan N, Harris‐McAllister V, Preston ME, Webb KA, O'Donnell DE. Effect of adjunct fluticasone propionate on airway physiology during rest and exercise in COPD. Respiratory Medicine. 2011/09/16 2011; Vol. 105, issue 12:1836‐45. [1532‐3064: (Electronic)] - PubMed
Hanania 2003 {published data only}
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    1. Mahler DA, Darken P, Brown CP, Knobil K. Predicting lung function responses to salmeterol/fluticasone propionate combination therapy in COPD [Abstract]. European Respiratory Journal 2003;22(Suppl 45):P429.
Hattotuwa 2002 {published data only}
    1. Gizycki MJ, Hattotuwa KL, Barnes N, Jeffery PK. Effects of fluticasone propionate on inflammatory cells in COPD: an ultrastructural examination of endobronchial biopsy tissue. Thorax 2002;57(9):799‐803. - PMC - PubMed
    1. Hattotuwa KL, Gizycki MJ, Ansari TW, Jeffery PK, Barnes NC. The effects of inhaled fluticasone on airway inflammation in chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2002;165(12):1592‐9. - PubMed
John 2005 {published data only}
    1. John M, Bosse S, Oltmanns U, Schumacher A, Witt C. Effects of inhaled HFA beclomethasone on pulmonary function and symptoms in patients with chronic obstructive pulmonary disease. Respiratory Medicine 2005;99(11):1418‐24. - PubMed
    1. John M, Bosse S, Schumacher A, Oltmanns U, Witt C. Effects of inhaled beclomethasone HFA 134 (qvar/ventoiair) on health related quality of life in patients with chronic obstructive pulmonary disease [Abstract]. American Thoracic Society 2005 International Conference. 2005:Poster A43.
Kerstjens 1992 {published data only}
    1. Kaptein AA, Brand PL, Dekker FW, Kerstjens HA, Postma DS, Sluiter HJ. Quality‐of‐life in a long‐term multicentre trial in chronic nonspecific lung disease: assessment at baseline. The Dutch CNSLD Study Group. European Respiratory Journal 1993;6(10):1479‐84. - PubMed
    1. Kerstjens HA, Brand PL, Quanjer PH, Bruggen‐Bogaarts BA, Koeter GH, Postma DS. Variability of bronchodilator response and effects of inhaled corticosteroid treatment in obstructive airways disease. Dutch CNSLD Study Group. Thorax 1993;48(7):722‐9. - PMC - PubMed
    1. Kerstjens HA, Brand PL, Jong PM, Koeter GH, Postma DS. Influence of treatment on peak expiratory flow and its relation to airway hyperresponsiveness and symptoms. The Dutch CNSLD Study Group. Thorax 1994;49(11):1109‐15. - PMC - PubMed
    1. Kerstjens HA, Overbeek SE, Schouten JP, Brand PL, Postma DS. Airways hyperresponsivenes, bronchodilator response, allergy and smoking predict improvement in FEV1 during long‐term inhaled corticosteroid treatment. Dutch CNSLD Study Group. European Respiratory Journal 1993;6(6):868‐76. - PubMed
    1. Kerstjens HA, Postma DS, Doormaal JJ, Zanten AK, Brand PL, Dekhuijzen PN, et al. Effects of short‐term and long‐term treatment with inhaled corticosteroids on bone metabolism in patients with airways obstruction. Dutch CNSLD Study Group. Thorax 1994;49(7):652‐6. - PMC - PubMed
Lapperre 2009 {published data only}
    1. Lapperre TS, Snoeck‐Stroband JB, Gosman MM, Jansen DF, Schadewijk A, Thiadens HA, et al. Groningen Leiden Universities Corticosteroids in Obstructive Lung Disease Study Group. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Annals of Internal Medicine 2009;151(8):517‐27. - PubMed
Laptseva 2002 {published data only}
    1. Laptseva IM, Laptseva EA, Borshchevsky VV, Gurevich G, Kalechits O. Inhaled budesonide in the management of chronic obstructive pulmonary disease. European Respiratory Journal 2002;20(Suppl 38):244s.
LHS 2000 {published data only}
    1. Anthonisen NR, Connett JC, Murray RP. Smoking and lung function of Lung Health Study participants after 11 years. American Journal of Respiratory and Critical Care Medicine 2002;166(5):675‐9. - PubMed
    1. Eichenhorn MS, Wise RA, Madhok TC, Gerald LB, Bailey WC, Tashkin DP, et al. Lack of long‐term adverse adrenal effects from inhaled triamcinolone: Lung Health Study II. Chest 2003;124(1):57‐62. - PubMed
    1. Lung Health Study Research Group. Effect of inhaled triamcinolone on the decline in pulmonary function in chronic obstructive pulmonary disease. New England Journal of Medicine 2000;343(26):1902‐9. - PubMed
    1. Scanlon PD, Connett JE, Wise RA, Tashkin DP, Madhok T, Skeans M, et al. Loss of one density with inhaled triamcinolone in Lung Health Study II. American Journal of Respiratory and Critical Care Medicine 2004;170(12):1302‐9. - PubMed
    1. Tashkin DP, Murray HE, Skeans M, Murray RP. Skin manifestations of inhaled corticosteroids in COPD patients. Chest 2004;126(4):1123‐33. - PubMed
Llewellyn‐Jones 1996 {published data only}
    1. Llewellyn‐Jones CG, Harris TA, Stockley RA. Effect of fluticasone propionate on sputum of patients with chronic bronchitis and emphysema. American Journal of Respiratory and Critical Care Medicine 1996;153(2):616‐21. - PubMed
Loppow 2001 {published data only}
    1. Loppow D, Schleiss MB, Kanniess F, Taube C, Jorres RA, Magnussen H. In patients with chronic bronchitis a four week trial with inhaled steroids does not attenuate airway inflammation. Respiratory Medicine 2001;95(2):115‐21. - PubMed
Mahler 2002 {published data only}
    1. Mahler DA, Darken P, Brown CP, Knobil K. Predicting lung function responses to combination therapy in chronic obstructive pulmonary disease (COPD). http://www.abstracts2view.com 2003.
    1. Mahler DA, Wire P, Horstman D, Chang CN, Yates J, Fischer T, et al. Effectiveness of fluticasone propionate and salmeterol combination delivered via the Diskus device in the treatment of chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2002;166(8):1084‐91. - PubMed
    1. SFCA3006. A randomized, double‐blind, placebo‐controlled, parallel‐group trial evaluating the safety and efficacy of the DISKUS formulations of salmeterol (SAL) 50mcg BID and fluticasone propionate (FP) 500mcg BID individually and in combination as salmeterol 50mcg/fluticasone propionate 500mcg BID (SFC 50/500) compared to placebo in COPD subjects. http://ctr.gsk.co.uk 2004.
Mirici 2001 {published data only}
    1. Mirici A, Bektas Y, Ozbakis G, Erman Z. Effect of inhaled corticosteroids on respiratory function tests and airway inflammation in stable chronic obstructive pulmonary disease. Clinical Drug Investigation 2001;21(12):835‐42.
Nishimura 1999 {published data only}
    1. Nishimura K, Koyama H, Ikeda A, Tsukino M, Hajiro T, Mishima M, et al. The effect of high‐dose inhaled beclomethasone dipropionate in patients with stable COPD. Chest 1999;115(1):31‐7. - PubMed
Ozol 2005 {published data only}
    1. Ozol D, Aysan T, Solak ZA, Mogulkoc N, Veral A, Sebik F. The effect of inhaled corticosteroids on bronchoalveolar lavage cells and IL‐8 levels in stable COPD patients. Respiratory Medicine 2005;99(12):1494‐500. - PubMed
Paggiaro 1998 {published data only}
    1. FLIT97. A multi‐centre, randomised, double‐blind, parallel group study of the efficacy and safety of inhaled fluticasone propionate 1000µg daily with placebo in chronic obstructive pulmonary disease. http://ctr.gsk.co.uk 2005.
    1. Paggiaro PL, Dahle R, Bakran I, Frith L, Hollingworth K, Efthimiou J. Multicentre randomised placebo‐controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. International COPD Study Group. Lancet 1998;351(9105):773‐80. - PubMed
Pauwels 1999 {published data only}
    1. Johnell O, Pauwels R, Löfdahl C‐G, Laitinen LA, Postma DS, Pride NB, et al. Bone mineral density in patients with chronic obstructive pulmonary disease treated with budesonide Turbuhaler. European Respiratory Journal 2002;19(6):1058‐63. - PubMed
    1. Lofdahl CG, Postma DS, Laitinen LA, Ohlsson SV, Pauwels RA, Pride NB. The European Respiratory Society study on chronic obstructive pulmonary disease (EUROSCOP): recruitment methods and strategies. Respiratory Medicine 1998;92(3):467‐72. - PubMed
    1. Pauwels RA, Lofdahl CG, Laitinen LA, Schouten JP, Postma DS, Pride NB, et al. Long‐term treatment with inhaled budesonide in persons with mild chronic obstructive pulmonary disease who continue smoking. European Respiratory Society Study on Chronic Obstructive Pulmonary Disease. New England Journal of Medicine 1999;340(25):1948‐53. - PubMed
    1. Pauwels RA, Lofdahl CG, Pride NB, Postma DS, Laitinen LA, Ohlsson SV. European Respiratory Society study on chronic obstructive pulmonary disease (EUROSCOP): hypothesis and design. European Respiratory Journal 1992;5(10):1254‐61. - PubMed
Renkema 1996 {published data only}
    1. Renkema TE, Schouten JP, Koeter GH, Postma DS. Effects of long‐term treatment with corticosteroids in COPD. Chest 1996;109(5):1156‐62. - PubMed
    1. Grunsven PM, Schayck CP, Derenne JP, Kerstjens HA, Renkema TE, Postma DS, et al. Long term effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a meta‐analysis. Thorax 1999;54(1):7‐14. - PMC - PubMed
Robertson 1986 {published data only}
    1. Robertson AS, Gove RI, Wieland GA, Burge PS. A double‐blind comparison of oral prednisolone 40 mg/day with inhaled beclomethasone dipropionate 1500 ug/day in patients with adult onset chronic obstructive airways disease. European Journal of Respiratory Diseases 1986;146 Suppl:565‐9. - PubMed
Rutgers 1998 {published data only}
    1. Rutgers SR, Koeter GH, Mark TW, Postma DS. Short‐term treatment with budesonide does not improve hyperresponsiveness to adenosine 5'‐monophosphate in COPD. American Journal of Respiratory and Critical Care Medicine 1998;157(3 Pt 1):880‐6. - PubMed
Schermer 2009 {published data only}
    1. Chavannes NH, Schermer TR, Wouters EF, Akkermans RP, Dekhuijzen RP, Muris JW, et al. Predictive value and utility of oral steroid testing for treatment of COPD in primary care: the COOPT study. International Journal of COPD 2009;4:431‐6. - PMC - PubMed
    1. Schermer T, Chavannes N, Dekhuijzen R, Wouters E, Muris J, Akkermans R, et al. Fluticasone and N‐acetylcysteine in primary care patients with COPD or chronic bronchitis. Respiratory Medicine 2009;103(4):542‐51. - PubMed
SCO30002 2005 {unpublished data only}
    1. SCO 30002. A multicentre, randomised, double‐blind, parallel group, placebo‐controlled study to compare the efficacy and safety of inhaled salmeterol/fluticasone propionate combination product 25/250 µg two puffs bd and fluticasone propionate 250µg two puffs bd alone, all administered via metered dose inhalers (MDI), in the treatment of subjects with chronic obstructive pulmonary disease (COPD) for 52 weeks. GlaxoSmithKline Clinical Trial Register 2005.
Senderovitz 1999 {published data only}
    1. Senderovitz T, Vestbo J, Frandsen J, Maltbaek N, Norgaard M, Nielsen C, et al. Steroid reversibility test followed by inhaled budesonide or placebo in outpatients with stable chronic obstructive pulmonary disease. Respiratory Medicine 1999;93(10):715‐8. - PubMed
Shaker 2009 {published data only}
    1. Shaker SB, Dirksen A, Ulrik CS, Hestad M, Stavngaard T, Laursen LC, Maltbaek N, et al. The effect of inhaled corticosteroids on the development of emphysema in smokers assessed by annual computed tomography. COPD: Journal of Chronic Obstructive Pulmonary Disease 2009;6(2):104‐11. - PubMed
    1. Shaker SB, Stavngaard T, Laursen LC, Stoel BC, Dirksen A. Rapid fall in lung density following smoking cessation in COPD. COPD: Journal of Chronic Obstructive Pulmonary Disease 2011;8(1):2‐7. - PubMed
Sin 2004 {published data only}
    1. Sin DD, Lacy P, York E, Man SFP. Effects of fluticasone on systemic markers of inflammation in chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2004;170(7):760‐5. - PubMed
Sin 2008 {published data only}
    1. Sin DD, Man SF, Marciniuk DD, Ford G, FitzGerald M, Wong E, York E, et al. ABC (Advair, Biomarkers in COPD) Investigators. The effects of fluticasone with or without salmeterol on systemic biomarkers of inflammation in chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2008;177(11):1207‐14. - PubMed
Szafranski 2003 {published data only}
    1. Anderson P. Budesonide/formoterol in a single inhaler (Symbicort) provides early and sustained improvement in lung function in moderate to severe COPD. Thorax 2002;57(Suppl III):iii43.
    1. Calverley PMA. Effect of budesonide/formoterol on severe exacerbations and lung function in moderate to severe COPD. Thorax 2002;BTS Winter Meeting 2002:S145.
    1. Calverley PMA, Thompson NC, Olsson H. Budesonide/formoterol in a single inhaler sustains lung function improvements in COPD [Abstract]. European Respiratory Journal 2003;22(Suppl 45):P435.
    1. Campbell LM, Szafranski W. Budesonide/formoterol in a single inhaler (Symbicort) provides sustained relief from symptoms in moderate to severe COPD. Thorax. 2002; Vol. BTS Winter Meeting 2002:S143.
    1. Campbell LW, Szafranski W. Budesonide/formoterol in a single inhaler (Symbicort) reduces severe exacerbations in patients with moderate‐severe COPD. Thorax. 2002; Vol. BTS Winter Meeting 2002:S141.
Tashkin 2008 {published data only}
    1. Tashkin DP, Rennard SI, Martin P, Ramachandran S, Martin UJ, Silkoff PE, et al. SHINE (Division of Pulmonary, Critical Care Medicine. University of California, Los Angeles, California, USA). Efficacy and safety of budesonide and formoterol in one pressurized metered‐dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease: results of a 6‐month randomized clinical trial. Drugs 2008;68(14):1975‐2000. - PubMed
Thompson 1992 {published data only}
    1. Thompson AB, Mueller MB, Heires AJ, Bohling TL, Daughton D, Yancey SW, et al. Aerosolized beclomethasone in chronic bronchitis. Improved pulmonary function and diminished airway inflammation. American Review of Respiratory Disease 1992;146(2):389‐95. [MEDLINE: ] - PubMed
Thompson 2002 {published data only}
    1. Thompson WH, Carvalho P, Souza JP, Charan NB. Controlled trial of inhaled fluticasone propionate in moderate to severe COPD. Lung 2002;180(4):191‐201. - PubMed
van Grunsven 1999 {published data only}
    1. Grunsven PM, Schayck CP, Derenne JP, Kerstjens HA, Renkema TE, Postma DS, et al. Long term effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a meta‐analysis. Thorax 1999;54(1):7‐14. - PMC - PubMed
van Grunsven 2003 {published data only}
    1. Grunsven P, Schermer T, Akkermans R, Albers M, Boom G, Schayck O, et al. Short‐ and long‐term efficacy of fluticasone propionate in subjects with early signs and symptoms of chronic obstructive pulmonary disease. Results of the DIMCA study. Respiratory Medicine 2003;97(12):1303‐12. - PubMed
Verhoeven 2002 {published data only}
    1. Verhoeven GT, Garrelds IM, Hoogsteden HC, Zijlstra FJ. Effects of fluticasone propionate inhalation on levels of arachidonic acid metabolites in patients with chronic obstructive pulmonary disease. Mediators of Inflammation 2001;10(1):21‐6. - PMC - PubMed
    1. Verhoeven GT, Hegmans JP, Mulder PG, Bogaard JM, Hoogsteden HC, Prins JB. Effects of fluticasone propionate in COPD patients with bronchial hyperresponsiveness. Thorax 2002;57(8):694‐700. - PMC - PubMed
    1. Verhoeven GT, Wijkhuijs AJ, Hooijkaas H, Hoogsteden HC, Sluiter W. Effect of an inhaled glucocorticoid on reactive oxygen species production by bronchoalveolar lavage cells from smoking COPD patients. Mediators of Inflammation 2000;9(2):109‐13. - PMC - PubMed
Vestbo 1999 {published data only}
    1. Vestbo J, Sorensen T, Lange P, Brix A, Torre P, Viskum K. Long‐term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 1999;353(9167):1819‐23. [MEDLINE: ] - PubMed
Weiner 1995 {published data only}
    1. Weiner P, Weiner M, Azgad Y, Zamir D. Inhaled budesonide therapy for patients with stable COPD. Chest 1995;108(6):1568‐71. - PubMed
Weiner 1999 {published data only}
    1. Weiner P, Weiner M, Rabner M, Waizman J, Magadle R, Zamir D. The response to inhaled and oral steroids in patients with stable chronic obstructive pulmonary disease. Journal of Internal Medicine 1999;245(1):83‐9. - PubMed
Weir 1990a {published data only}
    1. Weir DC, Gove RI, Robertson AS, Burge PS. Corticosteroid trials in non‐asthmatic chronic airflow obstruction: a comparison of oral prednisolone and inhaled beclomethasone dipropionate. Thorax 1990;45(2):112‐7. [MEDLINE: ] - PMC - PubMed
    1. Weir DC, Gove RI, Robertson AS, Burge PS. Response to corticosteroids in chronic airflow obstruction: relationship to emphysema and airways collapse. European Respiratory Journal 1991;4(10):1185‐90. - PubMed
    1. Weir DC, Robertson AS, Gove RI, Burge PS. Time course of response to oral and inhaled corticosteroids in non‐asthmatic chronic airflow obstruction. Thorax 1990;45(2):118‐21. - PMC - PubMed
Weir 1999 {published data only}
    1. Weir DC, Bale GA, Bright P, Sherwood Burge P. A double‐blind placebo‐controlled study of the effect of inhaled beclomethasone dipropionate for 2 years in patients with nonasthmatic chronic obstructive pulmonary disease. Clinical & Experimental Allergy Supplement 1999;29(2):125‐8. - PubMed
Wempe 1992 {published data only}
    1. Wempe JB, Postma DS, Breederveld N, Kort E, Mark TW, Koeter GH. Effects of corticosteroids on bronchodilator action in chronic obstructive lung disease. Thorax 1992;47(8):616‐21. - PMC - PubMed
Yildiz 2004 {published data only}
    1. Yildiz F, Basyigit I, Yildirim E, Boyaci H, Ilgazli A. Does addition of inhaled steroids to combined bronchodilator therapy affect health status in patients with COPD?. Respirology 2004;9(3):352‐5. - PubMed

References to studies excluded from this review

Albers 2004 {published data only}
    1. Albers M, Schermer T, dan Boom G, Akkermans R, Schayck C, Herwaarden C, et al. Efficacy of inhaled steroids in undiagnosed subjects at high risk for COPD: results of the detection, intervention, and monitoring of COPD and asthma program. Chest 2004;126(6):1815‐24. - PubMed
Anonymous 1999 {published data only}
    1. Anonymous. Inhaled glucocorticoids do not help smokers with mild chronic obstructive pulmonary disease. Modern Medicine of Australia 1999;42(12):9.
Anonymous 2000 {published data only}
    1. Anonymous. Inhaled corticosteroids: their role in chronic obstructive pulmonary disease. MeReC Bulletin 2000;11(6):21‐4.
Balbi 2000 {published data only}
    1. Balbi B, Majori M, Bertacco S, Convertino G, Cuomo A, Donner CF, et al. Inhaled corticosteroids in stable COPD patients: do they have effects on cells and molecular mediators of airway inflammation?. Chest 2000;117(6):1633‐7. - PubMed
Bensch 2003 {published data only}
    1. Bensch G, Hampel F, Sachs H. Once‐daily, evening administration of mometasone furoate dry powder inhaler improves pulmonary function in patients with mild to moderate persistent asthma. European Respiratory Journal 2003;22(Suppl 45):282s.
Burge 1999 {published data only}
    1. Burge PS. Inhaled corticosteroids in COPD. Thorax 1999;54(7):655. - PMC - PubMed
Chan 1993 {published data only}
    1. Chan CHS, Cohen M, Pang J. The effects of inhaled corticosteroids on chronic airflow limitation. Asian Pacific Journal of Allergy and Immunology 1993;11(2):97‐101. - PubMed
Confalonieri 1998 {published data only}
    1. Confalonieri M, Mainardi E, Della Porta R, Bernorio S, Gandola L, Beghe B, et al. Inhaled corticosteroids reduce neutrophilic bronchial inflammation in patients with chronic obstructive pulmonary disease. Thorax 1998;53(7):583‐5. - PMC - PubMed
Corda 2008 {published data only}
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Cox 1999 {published data only}
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Dompeling 1992 {published data only}
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Dompeling 1993 {published data only}
    1. Dompeling E, Schayck CP, Grunsven PM, Herwaarden CLA, Akkermans R, Molema J, et al. Slowing the deterioration of asthma and chronic obstructive pulmonary disease observed during bronchodilator therapy by adding inhaled corticosteroids. Annals of Internal Medicine 1993;118(10):770‐8. - PubMed
Egan 1999 {published and unpublished data}
    1. Egan JJ, Maden C, Kalra S, Adams JE, Eastell R, Woodcock AA. A randomised, double blind study comparing the effects of beclomethasone and fluticasone on bone density over 2 years. European Respiratory Journal 1999;13(6):1267‐75. - PubMed
Engel 1989 {published data only}
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Fattore 2005 {published data only}
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Fazio 1986 {published data only}
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Guleria 2003 {published data only}
    1. Guleria R, Singh TR, Sinha S, Padhy K, Gupta K, Pande JN. Effect of single inhalation of a salbutamol, ipratropium bromide and beclomethasone on mucociliary clearance in patients with chronic obstructive airway disease. Indian Journal of Chest Diseases & Allied Sciences 2003;45(4):241‐6. - PubMed
Keatings 1997 {published data only}
    1. Keatings VM, Jatakanon A, Worsdell YM, Barnes PJ. Effects of inhaled and oral glucocorticoids on inflammatory indices in asthma and COPD. American Journal of Respiratory and Critical Care Medicine 1997;155:542‐8. - PubMed
Kozak‐Skzopek 1997 {published data only}
    1. Kozak‐Skzopek E, Ulmer WT. Inhalative Budesonid‐Therapie bei chronischer Bronchitis. Atemweg und Lungenerkrankheiten 1997;23(9):542‐6.
Matlin 1976 {unpublished data only}
    1. Matlin RA. The efficacy of steroid aerosol in chronic obstructive pulmonary disease (COPD). American Review of Respiratory Disease 1976;113(4):184.
Melani 1999 {published data only}
    1. Melani AS, Gregorio A. Four‐week nebulized beclomethasone dipropionate in stable COPD patients with exertional dyspnoea. Monaldi Archives for Chest Disease 1999;54(3):224‐7. - PubMed
Moller 1999 {published data only}
    1. Moller M, Haller S, Kiebart M, Cloes R. AeroBec Autohaler in patients with reversible chronic‐obstructive respiratory diseases. Atemwegs‐ Und Lungenkrankheiten 1999;25(3):160‐7.
Nava 2000 {published data only}
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Nishimura 2000 {published data only}
    1. Nishimura K, Ikeda A, Koyama H, Zhang M, Tsukino M, Hajiro T, et al. Additive effects of prednisolone and beclomethasone dipropionate in patients with stable chronic obstructive pulmonary disease. Pulmonary Pharmacology & Therapeutics 2000;13(5):225‐30. - PubMed
O'Brien 2001 {published data only}
    1. O'Brien A, Russo‐Magno P, Karki A, Hiranniramol S, Hardin M, Kaszuba M, et al. Effects of withdrawal of inhaled steroids in men with severe irreversible airflow obstruction. American Journal of Respiratory and Critical Care Medicine 2001;164(3):365‐71. - PubMed
Ouyang 1998 {published data only}
    1. Ouyang R, Yin B. Clinical study of inhaled corticosteroid in non‐asthmatic chronic obstructive pulmonary disease. Zhonghua Jie He He Hu Xi Za Zhi 1998;21(8):497‐9. - PubMed
Roth 1996 {published data only}
    1. Roth R. Inhaled corticosteroids are effective and well tolerated [Inhalative Glukokortikoide sind wirksam und gut verträglich]. Therapiewoche 1996;46(24):1380.
Sandrini 2003 {published data only}
    1. Sandrini A, Plit M, Glaville A, Bryant D, Yates DH. Effect of inhaled steroid withdrawal on exhaled nitric oxide in COPD: preliminary data [Abstract]. Thorax 2003;58(Suppl 3):iii86.
Sapey 2000 {published data only}
    1. Sapey E, Langford NJ, Kendall MJ. Inhaled corticosteroids and chronic obstructive pulmonary disease. Journal of Clinical Pharmacy & Therapeutics 2000;25(4):235‐8. - PubMed
Schuurmans 2001 {published data only}
    1. Schuurmans M, Soler M. COPD ‐ Therapie: Bronchodilatatoren und Steroide. Therapiewoche 2001;17(1):28‐32.
Spicuzza 2004 {published data only}
    1. Spicuzza L, Scuderi V, Prosperini G, Balsamo R, DiMara GU, Polosa R. Acute effect of inhaled fluticasone on airway hyperresponsiveness to adenosine 5'‐monophosphate in asthma and in COPD. American Thoracic Society 100th International Conference. 2004; Vol. A58 Poster K33.
Tsang 1999 {published data only}
    1. Tsang KW. Inhaled corticosteroids in COPD. Thorax 1999;54(2):186. - PubMed
Turker 2004 {published data only}
    1. Turker H, Karakurt Z, Durucu K, Sulu E, Boga S, Yavsan M. High dose inhaler corticosteroids in patients with COPD. European Respiratory Journal 2004;24(Suppl 48):289s.
van den Boom 2001 {published data only}
    1. Boom G, Rutten‐Van Molken MPMJ, Molema J, Tirimanna PRS, Weel C, Schayck CP. The cost effectiveness of early treatment with fluticasone propionate 250 mcg twice a day in subjects with obstructive airway disease: results of the DIMCA program. American Journal of Respiratory and Critical Care Medicine 2001;164(11):2057‐66. - PubMed
van der Valk 2002 {published data only}
    1. Valk P, Monninkhof E, Phalen J, Zielhuis G, Herwaarden C. Effect of discontinuation of inhaled corticosteroids in patients with chronic obstructive pulmonary disease: the COPE study. American Journal of Respiratory and Critical Care Medicine 2002;166(10):1358‐63. - PubMed
van Grunsven 2000 {published data only}
    1. Grunsven PM, Schayck CP, Deuveren M, Herwaarden CL, Akkermans RP, Weel C. Compliance during long‐term treatment with fluticasone propionate in subjects with early signs of asthma or chronic obstructive pulmonary disease (COPD): results of the Detection, Intervention, and Monitoring Program of COPD and Asthma (DIMCA) Study. Journal of Asthma 2000;37(3):225‐34. - PubMed
van Schayck 1995 {published data only}
    1. Schayck CP, Dompeling E, Rutten MP, Folgering H, Boom G, Weel C. The influence of an inhaled steroid on quality of life in patients with asthma or COPD. Chest 1995;107(5):1199‐205. - PubMed
Vestbo 2000 {published data only}
    1. Vestbo J, Sørensen T, Lange P, Brix A, Torre P, Viskum K. Long‐term effect of inhaled budesonide in patients with mild to moderate chronic obstructive lung disease. The Østerbro Study [Langtidsvirkningen af inhaleret budesonid hos patienter med mild og moderat kronisk obstruktiv lungesygdom. Østerbro lunge studie]. Ugeskrift for Læger 2000;162(4):493‐7. - PubMed
Watson 1992 {published data only}
    1. Watson A, Lim TW, Joyce H, Pride NB. Failure of inhaled corticosteroids to modify bronchoconstrictor or bronchodilator responsiveness in middle‐aged smokers with mild airflow obstruction. Chest 1992;101(2):350‐5. - PubMed
Weiner 1997 {published data only}
    1. Weiner P, Zamir D, Beckerman M. Inhaled budesonide for chronic obstructive pulmonary disease. Harefuah 1997;132(11):823. - PubMed
Weir 1993 {published data only}
    1. Weir DC, Burge PS. Effects of high dose inhaled beclomethasone dipropionate, 750 mcg and 1500 mcg twice daily, and 40 mg per day oral prednisolone on lung function, symptoms, and bronchial hyperresponsiveness in patients with non‐asthmatic chronic airflow obstruction. Thorax 1993;48(4):309‐16. - PMC - PubMed
Wesseling 1991 {published data only}
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