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Meta-Analysis
. 2020 Sep 14;9(9):CD011293.
doi: 10.1002/14651858.CD011293.pub3.

Sublingual immunotherapy for asthma

Rebecca Fortescue  1 , Kayleigh M Kew  2 , Marco Shiu Tsun Leung  3
Affiliations
Meta-Analysis

Sublingual immunotherapy for asthma

Rebecca Fortescue et al. Cochrane Database Syst Rev. .

Abstract

Background: Asthma is a common long-term respiratory disease affecting approximately 300 million people worldwide. Approximately half of people with asthma have an important allergic component to their disease, which may provide an opportunity for targeted treatment. Sublingual immunotherapy (SLIT) aims to reduce asthma symptoms by delivering increasing doses of an allergen (e.g. house dust mite, pollen extract) under the tongue to induce immune tolerance. Fifty-two studies were identified and synthesised in the original Cochrane Review in 2015, but questions remained about the safety and efficacy of sublingual immunotherapy for people with asthma.

Objectives: To assess the efficacy and safety of sublingual immunotherapy compared with placebo or standard care for adults and children with asthma.

Search methods: The original searches for trials from the Cochrane Airways Group Specialised Register (CAGR), ClinicalTrials.gov, WHO ICTRP, and reference lists of all primary studies and review articles found trials up to 25 March 2015. The most recent search for trials for the current update was conducted on 29 October 2019.

Selection criteria: We included parallel randomised controlled trials, irrespective of blinding or duration, that evaluated sublingual immunotherapy versus placebo or as an add-on to standard asthma management. We included both adults and children with asthma of any severity and with any allergen-sensitisation pattern. We included studies that recruited participants with asthma, rhinitis, or both, providing at least 80% of trial participants had a diagnosis of asthma. We selected outcomes to reflect recommended outcomes for asthma clinical trials and those most important to people with asthma. Primary outcomes were asthma exacerbations requiring a visit to the emergency department (ED) or admission to hospital, validated measures of quality of life, and all-cause serious adverse events (SAEs). Secondary outcomes were asthma symptom scores, exacerbations requiring systemic corticosteroids, response to provocation tests, and dose of inhaled corticosteroids (ICS).

Data collection and analysis: Two review authors independently screened the search results for included trials, extracted numerical data, and assessed risk of bias, all of which were cross-checked for accuracy. Any disagreements were resolved by discussion. We analysed dichotomous data as odds ratios (ORs) or risk differences (RDs) using study participants as the unit of analysis; we analysed continuous data as mean differences (MDs) or standardised mean differences (SMDs) using random-effects models. We considered the strength of evidence for all primary and secondary outcomes using the GRADE approach.

Main results: Sixty-six studies met the inclusion criteria for this update, including 52 studies from the original review. Most studies were double-blind and placebo-controlled, varied in duration from one day to three years, and recruited participants with mild or intermittent asthma, often with comorbid allergic rhinitis. Twenty-three studies recruited adults and teenagers; 31 recruited only children; three recruited both; and nine did not specify. The pattern of reporting and results remained largely unchanged from the original review despite 14 further studies and a 50% increase in participants studied (5077 to 7944). Reporting of primary efficacy outcomes to measure the impact of SLIT on asthma exacerbations and quality of life was infrequent, and selective reporting may have had a serious effect on the completeness of the evidence; 16 studies did not contribute any data, and a further six studies could only be included in a post hoc analysis of all adverse events. Allocation procedures were generally not well described; about a quarter of the studies were at high risk of performance or detection bias (or both); and participant attrition was high or unknown in around half of the studies. The primary outcome in most studies did not align with those of interest to the review (mostly asthma or rhinitis symptoms), and only two small studies reported our primary outcome of exacerbations requiring an ED or hospital visit; the pooled estimate from these studies suggests SLIT may reduce exacerbations compared with placebo or usual care, but the evidence is very uncertain (OR 0.35, 95% confidence interval (CI) 0.10 to 1.20; n = 108; very low-certainty evidence). Nine studies reporting quality of life could not be combined in a meta-analysis and, whilst the direction of effect mostly favoured SLIT, the effects were often uncertain and small. SLIT likely does not increase SAEs compared with placebo or usual care, and analysis by risk difference suggests no more than 1 in 100 people taking SLIT will have a serious adverse event (RD -0.0004, 95% CI -0.0072 to 0.0064; participants = 4810; studies = 29; moderate-certainty evidence). Regarding secondary outcomes, asthma symptom and medication scores were mostly measured with non-validated scales, which precluded meaningful meta-analysis or interpretation, but there was a general trend of SLIT benefit over placebo. Changes in ICS use (MD -17.13 µg/d, 95% CI -61.19 to 26.93; low-certainty evidence), exacerbations requiring oral steroids (studies = 2; no events), and bronchial provocation (SMD 0.99, 95% CI 0.17 to 1.82; low-certainty evidence) were not often reported. Results were imprecise and included the possibility of important benefit or little effect and, in some cases, potential harm from SLIT. More people taking SLIT had adverse events of any kind compared with control (OR 1.99, 95% CI 1.49 to 2.67; high-certainty evidence; participants = 4251; studies = 27), but events were usually reported to be transient and mild. Lack of data prevented most of the planned subgroup and sensitivity analyses.

Authors' conclusions: Despite continued study in the field, the evidence for important outcomes such as exacerbations and quality of life remains too limited to draw clinically useful conclusions about the efficacy of SLIT for people with asthma. Trials mostly recruited mixed populations with mild and intermittent asthma and/or rhinitis and focused on non-validated symptom and medication scores. The review findings suggest that SLIT may be a safe option for people with well-controlled mild-to-moderate asthma and rhinitis who are likely to be at low risk of serious harm, but the role of SLIT for people with uncontrolled asthma requires further evaluation.

Trial registration: ClinicalTrials.gov NCT01678807 NCT01700192 NCT01433523 NCT00660452 NCT01644617 NCT02231307 NCT02478398.

PubMed Disclaimer

Conflict of interest statement

RF: None known.

KMK: None known.

ML: None known.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Forest plot of comparison: 1 Sublingual immunotherapy versus control, outcome: 1.1 Exacerbation requiring ED or hospital visit.
4
4
Forest plot of comparison: 1 Sublingual immunotherapy versus control, outcome: 1.3 Serious adverse events.
5
5
Forest plot of comparison: 1 Sublingual immunotherapy versus control, outcome: 1.9 All adverse events.
6
6
Cates plot illustrating all adverse events (Analysis 1.9). In the control group, 465 out of 1000 people experienced an adverse event compared to 634 (95% CI 565 to 699) out of 1000 for the SLIT group, corresponding to a number needed to treat for an additional harmful outcome of 6 (95% CI 5 to 11).
1.1
1.1. Analysis
Comparison 1: Sublingual immunotherapy versus control, Outcome 1: Exacerbation requiring ED or hospital visit
1.3
1.3. Analysis
Comparison 1: Sublingual immunotherapy versus control, Outcome 3: Serious adverse events
1.6
1.6. Analysis
Comparison 1: Sublingual immunotherapy versus control, Outcome 6: Exacerbation requiring OCS
1.7
1.7. Analysis
Comparison 1: Sublingual immunotherapy versus control, Outcome 7: Response to provocation tests
1.8
1.8. Analysis
Comparison 1: Sublingual immunotherapy versus control, Outcome 8: ICS use
1.9
1.9. Analysis
Comparison 1: Sublingual immunotherapy versus control, Outcome 9: All adverse events
1.10
1.10. Analysis
Comparison 1: Sublingual immunotherapy versus control, Outcome 10: AQLQ
2.1
2.1. Analysis
Comparison 2: Subgroup and sensitivity analyses, Outcome 1: Adverse events by age
2.2
2.2. Analysis
Comparison 2: Subgroup and sensitivity analyses, Outcome 2: Adverse events by allergen
2.3
2.3. Analysis
Comparison 2: Subgroup and sensitivity analyses, Outcome 3: Adverse events by study duration
2.4
2.4. Analysis
Comparison 2: Subgroup and sensitivity analyses, Outcome 4: Adverse events (sensitivity for risk of bias: removing open‐label studies)
2.5
2.5. Analysis
Comparison 2: Subgroup and sensitivity analyses, Outcome 5: Adverse events (sensitivity analysis removing studies with mixed population of asthma and rhinitis)
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Shao 2014 {published data only}
    1. Shao J, Cui YX, Zheng YF, Peng HF, Zheng ZL, Chen JY, et al. Efficacy and safety of sublingual immunotherapy in children aged 3-13 years with allergic rhinitis. American Journal of Rhinology and Allergy 2014;28(2):131-9. - PubMed
Stelmach 2009 {published data only}
    1. Majak P, Kaczmarek-Wozniak J, Brzozowska A, Bobrowska-Korzeniowska M, Jerzynska J, Stelmach I. One-year follow-up of clinical and inflammatory parameters in children allergic to grass pollen receiving high-dose ultrarush sublingual immunotherapy. Journal of Investigational Allergology and Clinical Immunology 2010;20(7):602-6. - PubMed
    1. Stelmach I, Kaczmarek-Woźniak J, Majak P, Olszowiec-Chlebna M, Jerzynska J. Efficacy and safety of high-doses sublingual immunotherapy in ultra-rush scheme in children allergic to grass pollen. Clinical and Experimental Allergy 2009;39(3):401-8. - PubMed
Tanaka 2020 {published data only}
    1. Tanaka A, Tohda Y, Okamiya K, Azuma R, Terada I, Adachi M. Efficacy and safety of HDM SLIT tablet in Japanese adults with allergic asthma. Journal of Allergy and Clinical Immunology: In Practice 2020;8(2):710-20.e14. [DOI: 10.1016/j.jaip.2019.09.002] - DOI - PubMed
Tian 2014 {published data only}
    1. Tian M, Wang Y, Lu Y, Jiang YH, Zhao DY. Effects of sublingual immunotherapy for Dermatophagoides farinae on Th17 cells and CD4+CD25+ regulatory T cells in peripheral blood of children with allergic asthma. International Forum of Allergy and Rhinology 2014;4:371-5. - PubMed
Trieste 2017 {published data only}
    1. Trieste L, Silvestri M, Tosca MA, Turchetti G. Assessment and simulation of costs and qol for sublingual immunotherapy in paediatric asthma vs placebo: preliminary data. Value in Health 2017;20:A645-6.
Troise 2009 {published data only}
    1. Troise C, Voltolini S, Incorvaia C, La Grutta S, Bignardi D, Frati F. Efficacy and safety of sublingual immunotherapy with a high dose birch extract: a placebo-controlled study. Allergy 2009;64:465.
    1. Voltolini S, Troise C, Incorvaia C, Bignardi D, Di Cara G, Marcucci F. Effectiveness of high dose sublingual immunotherapy to induce a stepdown of seasonal asthma: a pilot study. Current Medical Research and Opinion 2010;26(1):37-40. - PubMed
Umanets 2017 {published data only}
    1. Umanets T, Pineda F, Antipkin Y, Barzylovich V, Lapshyn V. Sublingual immunotherapy to house dust mites in pediatric patients with co-morbid asthma. World Allergy Organization Journal 2017;10:A7.
Virchow 2016 {published data only}
    1. Backer V, Virchow JC, Villesen HH, Fejerskov PA, Riis B, Blay F. HDM sublingual AIT tablet is well-tolerated and effective in partly and uncontrolled allergic asthma. European Respiratory Journal 2014;44:P298.
    1. Demoly P, Lawton S, Villesen H, Virchow JC. Immunotherapy with SQ-HDM slit-tablet is effective in the treatment of allergic rhinitis and allergic asthma. Internal Medicine Journal 2016;45:16-7.
    1. Eriksson G, Nolte H, Ljorring C, Riis C, Virchow JC. A post-hoc analysis of a novel endpoint for asthma exacerbations in a SQ HDM SLIT-tablet phase III allergic asthma trial. European Journal of Allergy and Clinical Immunology 2018;73:70-1.
    1. Green W, Hahn-Pedersen J, Andreasen J, Norgaard M. SQ HDM slit-tablets in addition to pharmacotherapy are cost-effective compared to pharmacotherapy only in treating patients with allergic asthma. Value in Health 2015;18:A502-3.
    1. Hahn-Pedersen J, Worm M, Green W, Andreasen JN. Cost utility analysis of the SQ((R)) HDM SLIT-tablet in house dust mite allergic asthma patients in a German setting. Clinical and Translational Allergy 2016;6:35. - PMC - PubMed
Vourdas 1998 {published data only}
    1. Vourdas D, Syrigou E, Potamianou P, Carat F, Batard T, Andre C, et al. Double-blind, placebo-controlled evaluation of sublingual immunotherapy with standardized olive pollen extract in pediatric patients with allergic rhinoconjunctivitis and mild asthma due to olive pollen sensitization. Allergy 1998;53(7):662-72. - PubMed
Wang 2014 {published data only}
    1. Devillier P, Fadel R, De Beaumont O. House dust mite sublingual immunotherapy is safe in patients with mild-to-moderate, persistent asthma: a clinical trial. European Journal of Allergy and Clinical Immunology 2016;71(2):249-57. - PubMed
    1. Wang L, Yin J, Fadel R, Montagut A, Beaumont O, Devillier P. House dust mite sublingual immunotherapy is safe and appears to be effective in moderate, persistent asthma. Allergy 2014;69(9):1181-8. - PubMed
    1. Yin J, Wang L, Cao Z, Wang G, Huang K, Liu G, et al. Efficacy and safety of sublingual immunotherapy (SLIT) in patients with house dust mites asthma in China. Annals of Allergy, Asthma & Immunology 2010;105:A108.
    1. Yin J, Wang L, Cao Z, Wang G, Huang K, Liu G, et al. Efficacy and safety of sublingual immunotherapy in asthmatic patients allergic to house dust mites: a double-blind controlled study in China. Allergy: European Journal of Allergy and Clinical Immunology 2011;66:63-4.
Wang 2017 {published data only}
    1. Wang D, Zhang E, Xiao E. Effect of specific immunotherapy induced by Dermatophagoides farinae on treatment of children with combined allergic rhinitis and asthma syndrome. Biomedical Research 2017;28:8909-12.
Wood 2014 {published data only}
    1. Wood RA, Togias A, Wildfire J, Visness CM, Matsui EC, Gruchalla R, et al. Development of cockroach immunotherapy by the Inner-City Asthma Consortium. Journal of Allergy and Clinical Immunology 2014;133(3):846-52. - PMC - PubMed
Xian 2019 {published data only}
    1. Xian M, Feng M, Dong Y, Wei N, Su Q, Li J. Changes in CD4+CD25+FoxP3+ regulatory T cells and serum cytokines in sublingual and subcutaneous immunotherapy in allergic rhinitis with or without asthma. International Archives of Allergy and Immunology 2019;2:206. - PMC - PubMed
Yin 2016 {published data only}
    1. Yin G-Q, Jiang W-H, Wu P-Q, He C-H, Chen R-S. Clinical evaluation of sublingual administration of dust mite drops in the treatment of allergic asthma and allergic rhinitis of children. European Review for Medical and Pharmacological Sciences 2016;20(20):4348-53. - PubMed
Yukselen 2013 {published data only}
    1. Yukselen A, Kendirli S, Yilmaz M, Altintas D, Karakoc G. Two year follow-up of clinical and inflammation parameters in children monosensitised to mites undergoing subcutaneous and sublingual immunotherapy. Allergy 2012;67:521. - PubMed
    1. Yukselen A, Kendirli SG, Yilmaz M, Altintas DU, Karakoc GB. Effect of one-year subcutaneous and sublingual immunotherapy on clinical and laboratory parameters in children with rhinitis and asthma: a randomized, placebo-controlled, double-blind, double-dummy study. International Archives of Allergy and Immunology 2012;157(3):288-98. - PubMed
    1. Yukselen A, Kendirli SG, Yilmaz M, Altintas DU, Karakoc GB. Two year follow-up of clinical and inflammation parameters in children monosensitized to mites undergoing subcutaneous and sublingual immunotherapy. Asian Pacific Journal of Allergy and Immunology 2013;31(3):233-41. - PubMed
Zeldin 2013 {published data only}
    1. Zeldin RK, Demoly P, Betting P, Rodriguez P, Racaud A, Le Gall M. Sublingual tablets of house dust mite allergen extracts: results of a phase I study in adults with mite-associated allergic asthma. American Journal of Respiratory and Critical Care Medicine 2013;42:665s [P3157].
Zhang 2013 {published data only}
    1. Zhang LW, Zhang YF, You HL, Liu L, Yin JN. Clinical efficacy and safety of long-term sublingual immunotherapy with standardized dermatophagoides farinae drops in children with bronchial asthma. Journal of Jilin University Medicine Edition 2013;39(1):148-51.
Zhang 2015 {published data only}
    1. Zhang X, Jiang D, Liu R, Fang G. Long-term efficacy of Dermatophagoides farina drop specific immunotherapy on children with acarid allergic asthma. Pharmaceutical Care and Research 2015;15(4):287-9.
Zheng 2012 {published data only}
    1. Zheng BQ, Wang GL, Yang S. Efficacy of specific sublingual immunotherapy with dermatophagoides farinae drops in the treatment of cough variant asthma in children. Chinese Journal of Contemporary Pediatrics 2012;14(8):585-8. - PubMed
Zieglmayer 2016 {published data only}
    1. Horak F, Maloney J, Nelson SH, Bernstein DI, Li Z, Zieglmayer P, et al. Onset of action of house dust mite sublingual immunotherapy tablet (SLIT-T) using an environmental exposure chamber. European Journal of Allergy and Clinical Immunology 2014;69:610. - PubMed
    1. Nolte H, Maloney J, Nelson HS, Bernstein DI, Li Z, Jacobi H, et al. Effect of 12 SQ house dust mite sublingual immunotherapy tablet on asthma symptoms using an environmental exposure chamber. Annals of Allergy, Asthma & Immunology 2015;115:A112.
    1. Nolte H, Maloney J, Nelson HS, Bernstein DI, Li Z, Zieglmayer R, et al. Efficacy of house dust mite sublingual immunotherapy tablet on ocular symptoms using an environmental exposure chamber. Annals of Allergy, Asthma & Immunology 2014;113:A99-100.
    1. Zieglmayer P, Nolte H, Nelson HS, Bernstein DI, Kaur A, Jacobi H, et al. Long-term effects of a house dust mite sublingual immunotherapy tablet in an environmental exposure chamber trial. Annals of Allergy, Asthma & Immunology 2016;117(6):690-6. - PubMed

References to studies excluded from this review

Abdou 1993 {published data only}
    1. Abdou MA, Hanna KM, El Attar S, Abdel Nabi E, Hatem A, Abdel Ghaffar M. Influence of a bacterial extract, broncho-vaxom, on clinical and immunological parameters in patients with intrinsic asthma. International Journal of Immunotherapy 1993;9:127-33.
Agostinis 2009 {published data only}
    1. Agostinis F, Foglia C, Bruno ME, Falagiani P. Efficacy, safety and tolerability of sublingual monomeric allergoid in tablets given without up-dosing to pediatric patients with allergic rhinitis and/or asthma due to grass pollen. European Annals of Allergy and Clinical Immunology 2009;41:177-80. - PubMed
Andre 2000 {published data only}
    1. Andre C, Vatrinet C, Galvain S, Carat F, Sicard H. Safety of sublingual-swallow immunotherapy in children and adults. International Archives of Allergy and Immunology 2000;121:229-34. - PubMed
Andre 2003 {published data only}
    1. Andre C, Perrin-Fayolle M, Grosclaude M, Couturier P, Basset D, Cornillon J, et al. A double-blind placebo-controlled evaluation of sublingual immunotherapy with a standardized ragweed extract in patients with seasonal rhinitis. Evidence for a dose-response relationship. Allergo Journal 2005;14:S6-13. - PubMed
    1. Andre C, Perrin-Fayolle M, Grosclaude M, Couturier P, Basset D, Cornillon J, et al. A double-blind placebo-controlled evaluation of sublingual immunotherapy with a standardized ragweed extract in patients with seasonal rhinitis. Evidence for a dose-response relationship. International Archives of Allergy and Immunology 2003;131:111-8. - PubMed
Ariano 1998 {published data only}
    1. Ariano R, Panzani RC, Augeri G. Efficacy and safety of oral immunotherapy in respiratory allergy to Parietaria judaica pollen. A double-blind study. Journal of Investigational Allergology and Clinical Immunology 1998;8:155-60. - PubMed
Ariano 2001 {published data only}
    1. Ariano R, Spadolini I, Panzani RC. Efficacy of sublingual specific immunotherapy in Cupressaceae allergy using an extract of Cupressus arizonica. A double blind study. Allergologia et Immunopathologia 2001;29:238-44. - PubMed
Ariano 2005 {published data only}
    1. Ariano R, Panzani RC, Mistrello G. Efficacy of sublingual co-seasonal immunotherapy with a monomeric allergoid in Cupressaceae pollen allergy - preliminary data. European Annals of Allergy and Clinical Immunology 2005;37:103-8. - PubMed
Bergmann 2014 {published data only}
    1. Bergmann KC, Demoly P, Worm M, Fokkens WJ, Carrillo T, Tabar AI, et al. Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis. Journal of Allergy and Clinical Immunology 2014;133(6):1608-14. - PubMed
Bergmann 2016 {published data only}
    1. Bergmann K-C, Okamoto Y, Ambroisine L, Beaumont O. Efficacy and safety of 300IR and 500IR doses of house dust mite sublingual immunotherapy tablet in subjects with house dust mite-associated allergic rhinitis in two phase II/III studies. Allergy 2016;71:341.
Bernstein 2011 {published data only}
    1. Bernstein DI, Atiee GJ, Maloney J, Nolte H, Nayak AS. Safety of a short ragweed allergy immunotherapy tablet in adults with ragweed-induced allergic rhinoconjunctivitis and asthma [Abstract]. Journal of Allergy and Clinical Immunology 2011;127(2 Suppl):AB48.
Birk 2017 {published data only}
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Blaiss 2011 {published data only}
    1. Blaiss M, Maloney J, Nolte H, Gawchik S, Yao R, Skoner DP. Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents. Journal of Allergy and Clinical Immunology 2011;127:64-71, 71.e1-4. - PubMed
Bommarito 2009 {published data only}
    1. Bommarito L, Bruno M, Nebiolo F, Moschella A, Zanierato G, Mistrello G, et al. Efficacy and safety of sublingual immunotherapy with birch monomeric allergoid: a comparison of two different treatment regimens versus pharmacological one. Allergy 2009;64:151.
Buchanan 2004 {published data only}
    1. Buchanan A, Jones SM, Christie L, Althage KM, Sculrock AM, Helm RM. Treatment of egg allergy in children through oral desensitization [Abstract]. Journal of Allergy and Clinical Immunology 2005;115:S167.
    1. Buchanan AD, Christie L, Althage KM, Jones SM, Pons LA, Helm RM, et al. Treatment of egg allergy in children through oral desensitization [Abstract]. Journal of Allergy and Clinical Immunology 2004;113:S150.
Bufe 2004 {published data only}
    1. Bufe A, Ziegler-Kirbach E, Stoeckmann E, Heidemann P, Gehlhar K, Holland-Letz T, et al. Efficacy of sublingual swallow immunotherapy in children with severe grass pollen allergic symptoms: a double-blind placebo-controlled study. Allergy 2004;59:498-504. - PubMed
Bufe 2009 {published data only}
    1. Bufe A, Eberle P, Franke-Beckmann E, Funck J, Kimmig M, Klimek L, et al. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy. Journal of Allergy and Clinical Immunology 2009;123:167-73.e7. - PubMed
Cadario 2008 {published data only}
    1. Cadario G, Ciprandi G, Di Cara G, Fadel R, Incorvaia C, Marcucci F, et al. Comparison between continuous or intermittent schedules of sublingual immunotherapy for house dust mites: effects on compliance, patients' satisfaction, quality of life and safety. International Journal of Immunopathology and Pharmacology 2008;21:471-3. - PubMed
Cao 2007 {published data only}
    1. Cao LF, Lu Q, Gu HL, Chen YP, Zhang Y, Lu M, et al. Clinical evaluation for sublingual immunotherapy of allergic asthma and atopic rhinitis with Dermatophagoides Farinae Drops. Zhonghua er ke za zhi [Chinese Journal of Pediatrics] 2007;45:736-41. - PubMed
Clavel 1998 {published data only}
    1. Clavel R, Bousquet J, André C. Clinical efficacy of sublingual-swallow immunotherapy: a double-blind, placebo-controlled trial of a standardized five-grass-pollen extract in rhinitis. Allergy 1998;53:493-8. - PubMed
Cortellini 2010 {published data only}
    1. Cortellini G, Spadolini I, Patella V, Fabbri E, Santucci A, Severino M, et al. Sublingual immunotherapy for Alternaria-induced allergic rhinitis: a randomized placebo-controlled trial. Annals of Allergy, Asthma & Immunology 2010;105:382-6. - PubMed
Cosmi 2006 {published data only}
    1. Cosmi L, Santarlasci V, Angeli R, Liotta F, Maggi L, Frosali F, et al. Sublingual immunotherapy with Dermatophagoides monomeric allergoid down-regulates allergen-specific immunoglobulin E and increases both interferon-gamma- and interleukin-10-production. Clinical and Experimental Allergy 2006;36:261-72. - PubMed
Cox 2012 {published data only}
    1. Cox LS, Casale TB, Nayak AS, Bernstein DI, Creticos PS, Ambroisine L, et al. Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE. Journal of Allergy and Clinical Immunology 2012;130(6):1327-34. - PubMed
Creticos 2014 {published data only}
    1. Creticos PS, Esch RE, Couroux P, Gentile D, D'Angelo P, Whitlow B, et al. Randomized, double-blind, placebo-controlled trial of standardized ragweed sublingual-liquid immunotherapy for allergic rhinoconjunctivitis. Journal of Allergy and Clinical Immunology 2014;133:751-8. - PubMed
D'Ambrosio 1996 {published data only}
    1. D'Ambrosio FP, Ricciardi L, Isola S, Savi E, Parmiani S, Puccinelli P, et al. Rush sublingual immunotherapy in Parietaria allergic patients. Allergologia et Immunopathologia 1996;24:146-51. - PubMed
D'Anneo 2008 {published data only}
    1. D'Anneo RW, Arena A, Gammeri E, Bruno ME, Falagiani P, Riva G, et al. Parietaria sublingual allergoid immunotherapy with a co-seasonal treatment schedule. Allergologia et Immunopathologia 2008;36:79-84. - PubMed
D'Anneo 2010 {published data only}
    1. D'Anneo R, Bruno M, Falagiani P. Allergoid sublingual immunotherapy: a new 4-day induction phase in patients allergic to house dust mites. Allergy 2010;65:668. - PubMed
    1. D'Anneo RW, Bruno ME, Falagiani P. Sublingual allergoid immunotherapy: a new 4-day induction phase in patients allergic to house dust mites. International Journal of Immunopathology and Pharmacology 2010;23:553-60. - PubMed
Deb 2012 {published data only}
    1. Deb A, Mukherjee S, Pal J, Bhattacharya A, Bhattacharyya A, Deb N. A prospective quasi-experimental study on the effect of sub-lingual immunotherapy with multiple allergens in allergic bronchial asthma. Journal of Clinical and Diagnostic Research 2012;6:246-51.
de Blay 2007 {published data only}
    1. Blay F, Barnig C, Kanny G, Purohit A, Leynadier F, Tunon de Lara JM, et al. Sublingual-swallow immunotherapy with standardized 3-grass pollen extract: a double-blind, placebo-controlled study. Annals of Allergy, Asthma & Immunology 2007;99:453-61. - PubMed
de Bot 2008 {published data only}
    1. Bot CM, Moed H, Berger MY, Röder E, Groot H, Jongste JC, et al. Randomized double-blind placebo-controlled trial of sublingual immunotherapy in children with house dust mite allergy in primary care: study design and recruitment. BMC Family Practice 2008;9:59. - PMC - PubMed
Demoly 2019 {published data only}
    1. Demoly P, Corren J, Creticos P, De Blay F, Douville I, Gevaert P, et al. OA0019 Efficacy and safety of the 300 IR sublingual tablet for the treatment of house dust mite-associated allergic rhinitis: a multicentre, international, dbpc, randomized phase III clinical trial. Allergy 2019;74 (Suppl 106):14.
Didier 2011 {published data only}
    1. Didier A, Worm M, Horak F, Melac M, De Beaumont O, Le Gall M, et al. Sustained efficacy and safety of a pre-coseasonal 300IR 5-grass pollen SLIT tablet over 3 pollen seasons in adult SAR [Abstract]. Journal of Allergy and Clinical Immunology 2011;127:AB151. - PubMed
Di Rienzo 2003 {published data only}
    1. Di Rienzo V, Marcucci F, Puccinelli P, Parmiani S, Frati F, Sensi L, et al. Long-lasting effect of sublingual immunotherapy in children with asthma due to house dust mite: a 10-year prospective study. Clinical and Experimental Allergy 2003;33:206-10. - PubMed
    1. Passalacqua G, Di Rienzo V, Marcucci F, Puccinelli P, Parmiani S, Frati F, et al. Long-lasting efficacy of sublingual immunotherapy in children. Journal of Allergy and Clinical Immunology 2003;111(2 Suppl 1):S72. - PubMed
Di Rienzo 2006 {published data only}
    1. Di Rienzo V, Pucci S, Romano A, Alo SD, Incorvaia C, Frati F. High dose SLIT with Juniperus Ashei extract improves quality of life in patients with cypress pollinosis [Abstract]. Journal of Allergy and Clinical Immunology 2006;117:S159.
Drachenberg 2001 {published data only}
    1. Drachenberg KJ, Pfeiffer P, Urban E. Sublingual immunotherapy - results from a multi-centre, randomised, double-blind, placebo-controlled study with a standardised birch and grass/rye pollen extract. Allergologie 2001;24:525-34.
Durham 2012 {published data only}
    1. Dahl R, Kapp A, Ribel M, Durham SR. Longitudinal study of sublingual immunotherapy with SQ standardized grass allergen tablet - interim safety results. Journal of Allergy and Clinical Immunology 2006;117:S220.
    1. Durham SR, Emminger W, Kapp A, De Monchy JGR, Rak S, Scadding GK, et al. SQ-standardized sublingual grass immunotherapy: confirmation of disease modification 2 years after 3 years of treatment in a randomized trial. Journal of Allergy and Clinical Immunology 2012;129:717-25.e5. - PubMed
    1. Nasser S, Vestenbaek U, Beriot-Mathiot A, Poulsen PB. Cost-effectiveness of specific immunotherapy with Grazax in allergic rhinitis co-existing with asthma. Allergy 2008;63:1624-9. - PubMed
Emminger 2017 {published data only}
    1. Emminger W, Cardona V, Fogh BS, Rehm D, Smith IM, Backer V. House dust mite SLIT-tablet is well tolerated in patients with house dust mite respiratory allergic disease. Allergy 2017;72:119-20. - PMC - PubMed
    1. Emminger W, Hernandez MD, Cardona V, Smeenk F, Fogh BS, Calderon MA, et al. The SQ house dust mite SLIT-tablet is well tolerated in patients with house dust mite respiratory allergic disease. International Archives of Allergy and Immunology 2017;174(1):35-44. - PMC - PubMed
    1. Emminger W, Smeenk F, Guzik T, Dyczek A, Fejerskov P, Brodersen R. The SQ HDM SLIT-tablet is well-tolerated in respiratory allergic disease; results from 2 DBPC phase III trials (MERIT and MITRA). Allergy 2014;69:184.
Fancello 2008 {published data only}
    1. Fancello P, Atzeni I, Bruno M. Sublingual allergoid immunotherapy with a 4-day updosing phase versus traditional initial scheme, or drugs alone. A controlled, randomised study in rhinitic patients with or without mild allergic asthma. Allergy 2008;63:1067.
Feliziani 1995 {published data only}
    1. Feliziani V, Lattuada G, Parmiani S, Dall'Aglio PP. Safety and efficacy of sublingual rush immunotherapy with grass allergen extracts. A double blind study. Allergologia et Immunopathologia 1995;23:224-30. - PubMed
Ferrer 2003 {published data only}
    1. Ferrer A, García-Sellés J. Significant improvement in symptoms, skin test, and specific bronchial reactivity: after 6 months of treatment with a depigmented, polymerized extract of Dermatophagoides pteronyssinus and D. farinae. Journal of Investigational Allergology and Clinical Immunology 2003;13:244-51. - PubMed
Germouty 1986 {published data only}
    1. Germouty J. Immunotherapy of recurrent respiratory infections. Double-blind study of a new immunomodulator in 60 patients. Revue de Pneumologie Clinique 1986;42:207-13. - PubMed
Giovane 1994 {published data only}
    1. Giovane AL, Bardare M, Passalacqua G, Ruffoni S, Scordamaglia A, Ghezzi E, et al. A three-year double-blind placebo-controlled study with specific oral immunotherapy to Dermatophagoides: evidence of safety and efficacy in paediatric patients. Clinical and Experimental Allergy 1994;24:53-9. - PubMed
Gozalo 1997 {published data only}
    1. Gozalo F, Martín S, Rico P, Alvarez E, Cortés C. Clinical efficacy and tolerance of two year Lolium perenne sublingual immunotherapy. Allergologia et Immunopathologia 1997;25:219-27. - PubMed
Gunawardana 2017 {published data only}
    1. Gunawardana NC, Jain A, Zhao Q, Tsai K, George L, Selverian D, et al. Biomarkers of 12 SQ house dust mite sublingual immunotherapy (SLIT)-tablet treatment after nasal allergen challenge. Journal of Allergy and Clinical Immunology 2017;139:AB192. - PubMed
Hedlin 1999 {published data only}
    1. Hedlin G, Wille S, Browaldh L, Hildebrand H, Holmgren D, Lindfors A, et al. Immunotherapy in children with allergic asthma: effect on bronchial hyperreactivity and pharmacotherapy. Journal of Allergy and Clinical Immunology 1999;103:609-14. - PubMed
Hirsch 1997 {published data only}
    1. Hirsch T, Sähn M, Leupold W. Double-blind placebo-controlled study of sublingual immunotherapy with house dust mite extract (D.pt.) in children. Pediatric Allergy and Immunology 1997;8:21-7. - PubMed
Holt 2013 {published data only}
    1. Holt PG, Sly PD, Sampson HA, Robinson P, Loh R, Lowenstein H, et al. Prophylactic use of sublingual allergen immunotherapy in high-risk children: a pilot study. Journal of Allergy and Clinical Immunology 2013;132:991-3.e1. - PubMed
Ibañez 2007 {published data only}
    1. Ibañez MD, Kaiser F, Knecht R, Armentia A, Schöpfer H, Tholstrup B, et al. Safety of specific sublingual immunotherapy with SQ standardized grass allergen tablets in children. Pediatric Allergy and Immunology 2007;18:516-22. - PubMed
Jerzynska 2016 {published data only}
    1. Jerzynska J, Stelmach W, Rychlik B, Lechanska J, Podlecka D. The clinical effect of vitamin D supplementation combined with grass-specific sublingual immunotherapy in children with allergic rhinitis. Allergy and Asthma Proceedings 2016;37(2):105-14. - PubMed
Kim 2018 {published data only}
    1. Kim JH, Lee JH, Ye YM, Lee JH, Park JW, Hur GY, et al. Efficacy and safety of sublingual immunotherapy in elderly rhinitis patients sensitized to house dust mites. Allergy, Asthma and Immunology Research 2018;10(6):675-85. - PMC - PubMed
Klimek 2015 {published data only}
    1. Klimek L, Bachert C, Lukat KF, Pfaar O, Meyer H. Allergy immunotherapy with a hypoallergenic recombinant birch pollen allergen rBet v 1-FV in a randomized controlled trial. Clinical and Translational Allergy 2015;5:28. - PMC - PubMed
Leonardi 2009 {published data only}
    1. Leonardi S, Spicuzza L, La Rosa M. High-dose sublingual immunotherapy in children at 8-year follow-up. Annals of Allergy, Asthma & Immunology 2009;102:259-60. - PubMed
Leonardi 2010 {published data only}
    1. Leonardi S, Arena A, Bruno ME, Cannaò PM, D'Anneo RW, Falagiani P, et al. Olea sublingual allergoid immunotherapy administered with two different treatment regimens. Allergy and Asthma Proceedings 2010;31:e25-9. - PubMed
Leonardi 2015 {published data only}
    1. Leonardi S, Castro A, Lanzafame A, Parisi G, Filippelli M, Spicuzza L. Safety and efficacy of sublingual specific immunotherapy to house dust mite using a different dosage: a pilot study. Journal of Biological Regulators and Homeostatic Agents 2015;29(2):84-8. - PubMed
Li 2014 {published data only}
    1. Li P, Li Q, Huang Z, Chen W, Lu Y. Efficacy and safety of house dust mite sublingual immunotherapy in monosensitized and polysensitized children with respiratory allergic diseases. International Forum of Allergy and Rhinology 2014;4(10):796-801. - PubMed
Lombardi 2001 {published data only}
    1. Lombardi C, Gargioni S, Venturi S, Zoccali P, Canonica GW, Passalacqua G. Controlled study of preseasonal immunotherapy with grass pollen extract in tablets: effect on bronchial hyperreactivity. Journal of Investigational Allergology and Clinical Immunology 2001;11:41-5. - PubMed
Ma 2010 {published data only}
    1. Ma XP, Muzhapaer D. Efficacy of sublingual immunotherapy in children with dust mite allergic asthma. Zhongguo dang dai er ke za zhi [Chinese Journal of Contemporary Pediatrics] 2010;12:344-7. - PubMed
Majak 2009 {published data only}
    1. Majak P, Rychlik B, Stelmach I. The effect of oral steroids with and without vitamin D3 on early efficacy of immunotherapy in asthmatic children. Clinical and Experimental Allergy 2009;39(12):1830-41. - PubMed
Mäkelä 2016 {published data only}
    1. Mäkelä M, Savolainen J, Laursen MK, Andersen JS, Riis B. Results from a double-blind, randomised, placebo-controlled, dose-response evaluation of SQ tree sublingual allergy immunotherapy (SLIT)-tablet. Allergy 2016;71:247.
Maksimovic 2002 {published data only}
    1. Maksimovic TL, Radic S, Popovic M, Begovic D, Voros M. Effects of oromucosal immunotherapy (SLIT) in children with respiratory allergy [Abstract]. European Respiratory Journal 2002;20:525s.
Malling 2005 {published data only}
    1. Malling HJ, Lund L, Ipsen H, Poulsen LK. Safety and immunological changes during tablet based specific immunotherapy [Abstract]. Journal of Allergy and Clinical Immunology 2005;115:S161.
Malling 2009 {published data only}
    1. Malling HJ, Montagut A, Melac M, Patriarca G, Panzner P, Seberova E, et al. Efficacy and safety of 5-grass pollen sublingual immunotherapy tablets in patients with different clinical profiles of allergic rhinoconjunctivitis. Clinical and Experimental Allergy 2009;39:387-93. - PMC - PubMed
Maloney 2014 {published data only}
    1. Maloney J, Bernstein DI, Hebert J, White M, Fisher R, Casale TB, et al. The efficacy and safety of the short ragweed sublingual immunotherapy tablet MK-3641 is similar in asthmatic and nonasthmatic subjects treated for allergic rhinitis with/without conjunctivitis (AR/C). Journal of Allergy and Clinical Immunology 2014;133:AB218.
Marappan 2007 {published data only}
    1. Marappan M. Sublingual immunotherapy is an established therapy for house dust mite sensitive allergic rhinitis and/or asthma [Abstract]. European Respiratory Journal 2007;30:623s [P3652].
Marappan 2008 {published data only}
    1. Marappan M. Changes in clinical status and serum IGE levels following sublingual immunotherapy for 2 years in patients with allergic rhinitis and/or asthma due to house dust mite [Abstract]. Chest 2008;134:43001s.
Maria 2004 {published data only}
    1. Maria D, Dervaderics M, Dervaderics BT. Long-lasting effect of sublingual ragweed immunotherapy: a 5-year prospective study [Abstract]. Journal of Allergy and Clinical Immunology 2004;113:S105.
Marogna 2004 {published data only}
    1. Marogna M, Spadolini I, Massolo A, Canonica GW, Passalacqua G. Randomized controlled open study of sublingual immunotherapy for respiratory allergy in real-life: clinical efficacy and more. Allergy 2004;59:1205-10. - PubMed
Marogna 2010 {published data only}
    1. Marogna M, Colombo F, Cerra C, Bruno M, Massolo A, Canonica GW, et al. The clinical efficacy of a sublingual monomeric allergoid at different maintenance doses: a randomized controlled trial. International Journal of Immunopathology and Pharmacology 2010;23:937-45. - PubMed
Marogna 2012 {published data only}
    1. Marogna M, Braidi C, Bruno ME, Colombo C, Colombo F, Massolo A, et al. The contribution of sublingual immunotherapy to the achievement of control in birch-related mild persistent asthma: a real-life randomised trial. Allergologia et Immunopathologia 2013;41:216-24. - PubMed
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Marogna 2014 {published data only}
    1. Marogna M, Braidi C, Colombo C, Colombo F, Palumbo L. Sublingual allergoid immunotherapy for mites in the prevention of recurrent respiratory infections: a prospective real life study. Allergy: European Journal of Allergy and Clinical Immunology 2014;69:509.
Mauro 2004 {published data only}
    1. Mauro M, Russello M, Incorvia C, D'Ingianna E, Gazzola G. Efficacy and safety of subcutaneous and sublingual immunotherapy in birch pollinosis [Abstract]. Journal of Allergy and Clinical Immunology 2004;113:S108. - PubMed
Mayorga 2004 {published data only}
    1. Mayorga C, Corzo JL, Antunez C, Torres MJ, Cornejo-Garcia JA, Santos R, et al. Comparison of immunological changes induced by sublingual and subcutaneous specific immunotherapy in children with allergic respiratory diseases [Abstract]. Journal of Allergy and Clinical Immunology 2004;113:S108.
Melarnanci 2004 {published data only}
    1. Melarnanci C, Matteoli MC. Efficacy of allergoid sublingual immunotherapy in children with asthma and/or allergic rhinoconjunctivitis: comparison study with drugs [Abstract]. Journal of Allergy and Clinical Immunology 2004;113:S111.
Mezei 2018 {published data only}
    1. Mezei G, Gonczi F, Nagy A, Balogh K, Mohacsi K, Mohacsi E. A pre-coseasonal course with monomeric allergoid sublingual tablets is very well tolerated and reliefs the symptoms of seasonal rhinoconjunctivitis in Hungarian patients allergic to ragweed pollen. Allergy 2018;73:121-2.
Moreno‐Ancillo 2007 {published data only}
    1. Moreno-Ancillo A, Moreno C, Ojeda P, Domínguez C, Barasona MJ, García-Cubillana A, et al. Efficacy and quality of life with once-daily sublingual immunotherapy with grasses plus olive pollen extract without updosing. Journal of Investigational Allergology and Clinical Immunology 2007;17:399-405. - PubMed
Murphy 2013 {published data only}
    1. Murphy K, Gawchik S, Bernstein D, Andersen J, Pedersen MR. A phase 3 trial assessing the efficacy and safety of grass allergy immunotherapy tablet in subjects with grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma. Journal of Negative Results in Biomedicine 2013;12:10. - PMC - PubMed
Mussler 2009 {published data only}
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NCT00200850 {published data only}
    1. Bush R, Swenson C, Fahlberg B, Bernstein J, Gaworski K, Sanchez H, et al. Safety of sublingual house dust mite (HDM) immunotherapy: a randomized, double-blind, placebo-controlled U.S. trial [Abstract]. Journal of Allergy and Clinical Immunology 2009;123:273.
    1. Bush RK, Swenson C, Fahlberg B, Evans MD, Esch R, Morris M, et al. House dust mite sublingual immunotherapy: results of a US trial. Journal of Allergy and Clinical Immunology 2011;127:974-81.e1-7. - PubMed
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NCT00250263 {published data only}
    1. Gardner LM, Thien FC, Douglass JA, Rolland JM, O'Hehir RE. Induction of T 'regulatory' cells by standardized house dust mite immunotherapy: an increase in CD4+ CD25+ interleukin-10+ T cells expressing peripheral tissue trafficking markers. Clinical and Experimental Allergy 2004;34:1209-19. - PubMed
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    1. O'Hehir RE, Gardner LM, Leon MP, Hales BJ, Biondo M, Douglass JA, et al. House dust mite sublingual immunotherapy: the role for transforming growth factor-beta and functional regulatory T cells. American Journal of Respiratory and Critical Care Medicine 2009;180:936-47. - PubMed
NCT02014623 {published data only}
    1. NCT02014623. Immunological mechanisms of Oralair® in patients with seasonal allergic rhinitis. clinicaltrials.gov/ct2/show/NCT02014623 (first received 18 December 2013).
NCT02231307 {published data only}
    1. Pfaar O, Bachert C, Kuna P, Panzner P, Dzupinova M, Yu D, et al. Early efficacy onset, already prior to the start of the birch pollen season, after sublingual immunotherapy with a liquid birch pollen extract. Allergy 2017;72:485.
    1. Pfaar O, Kuna P, Panzner P, Dzupinova M, Klimek L, Nimwegen M, et al. Phase III trial with allergen specific sublingual immunotherapy in birch allergic patients: significant improvements in quality of life scores and significant changes in immunoglobulins with acceptable safety. Allergy 2016;71:453-4.
Nelson 2011 {published data only}
    1. Nelson HS, Nolte H, Creticos P, Maloney J, Wu J, Bernstein DI. Efficacy and safety of timothy grass allergy immunotherapy tablet treatment in North American adults. Journal of Allergy and Clinical Immunology 2011;127:72-80, 80.e1-2. - PubMed
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Nolte 2014 {published data only}
    1. Nolte H, Maloney J, Nelson HS, Bernstein DI, Li Z, Zieglmayer R, et al. Dose-finding efficacy and safety trial of house dust mite sublingual immunotherapy tablet, MK-8237, using an environmental exposure chamber. Journal of Allergy and Clinical Immunology 2014;133:AB403. - PubMed
Nolte 2019 {published data only}
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Pozzan 2010 {published data only}
    1. Milani M, Pozzan M. Efficacy of sublingual specific immunotherapy drops in patients with respiratory allergy to Alternaria alternata: a randomised, assessor-blinded, patient reported outcome, controlled 3-year trial [Abstract]. In: 30th Congress of the European Academy of Allergy and Clinical Immunology; 2011 11-15 June; Istanbul. Vol. 66. 2011:505-6.
    1. Pozzan M, Milani M. Efficacy of sublingual specific immunotherapy drops in patients with respiratory allergy to alternaria alternata: a randomised controlled 3-year trial [Abstract]. In: XXIX EAACI Congress of the European Academy of Allergy and Clinical Immunology; 2010 5-9 June; London. Vol. 65. 2010:1921.
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Pradalier 1999 {published data only}
    1. Pradalier A, Basset D, Claudel A, Couturier P, Wessel F, Galvain S, et al. Sublingual-swallow immunotherapy (SLIT) with a standardized five-grass-pollen extract (drops and sublingual tablets) versus placebo in seasonal rhinitis. Allergy 1999;54:819-28. - PubMed
Purello‐D'Ambrosio 1999 {published data only}
    1. Purello-D'Ambrosio F, Gangemi S, Isola S, La Motta N, Puccinelli P, Parmiani S, et al. Sublingual immunotherapy: a double-blind, placebo-controlled trial with Parietaria judaica extract standardized in mass units in patients with rhinoconjunctivitis, asthma, or both. Allergy 1999;54:968-73. - PubMed
Queiros 2012 {published data only}
    1. Queiros M, Silva D, Simanc I, Ynouec L, Araujoc N, Pereira F, et al. Clinical efficacy and mucosal/systemic antibody response changes after sublingual immunotherapy in mite-allergic children: a randomized double-blind, placebo-controlled study in Brazil. In: 22nd World Allergy Congress; 2011 Nov 4-8; Cancun. Vol. 5. 2012:S83-4.
    1. Queiros MGJ, Silva DAO, Siman IL, Ynoue LH, Araujo NS, Pereira FL, et al. Modulation of mucosal/systemic antibody response after sublingual immunotherapy in mite-allergic children. Pediatric Allergy and Immunology 2013;24:752-61. - PubMed
Quercia 2011 {published data only}
    1. Quercia O, Bruno ME, Compalati E, Falagiani P, Mistrello G, Stefanini GF. Efficacy and safety of sublingual immunotherapy with grass monomeric allergoid: comparison between two different treatment regimens. European Annals of Allergy and Clinical Immunology 2011;43:176-83. - PubMed
Reich 2011 {published data only}
    1. Reich K, Gessner C, Eike W, Schwab J, Fejerskov P, Emminger W. In-season initiation of treatment with SQ standardised grass allergy immunotherapy tablet induces an immunomodulatory response and seems to be well tolerated. Allergy 2009;64:549-50.
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Reinert 1983 {published data only}
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Rodriguez 2006 {published data only}
    1. Boquete M, Rodriguez F, Tabar A, Ibanez D, Nieto A, Torre-Martinez F. Assessment of a new treatment schedule in sublingual immunotherapy: a randomized double blind placebo controlled multi-centre study [Abstract]. Journal of Allergy and Clinical Immunology 2006;117:S162.
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Rodriguez Santos 2008 {published data only}
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Romo 1996 {published data only}
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Shore 1980 {published data only}
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Srivastava 2007 {published data only}
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Stosovic 2019 {published data only}
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Tabar 2008 {published data only}
    1. Tabar AI, Lizaso MT, García BE, Gómez B, Echechipía S, Aldunate MT, et al. Double-blind, placebo-controlled study of Alternaria alternata immunotherapy: clinical efficacy and safety. Pediatric Allergy and Immunology 2008;19:67-75. - PubMed
Tari 1990 {published data only}
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Urbanek 1982 {published data only}
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Villesen 2017 {published data only}
    1. Villesen HH, Nelson HS, Bernstein DI, Nolte H, Seitzberg D, Stage BS. A house dust mite SLIT-tablet reduces symptoms of house dust mite allergic rhinitis in adolescents - pooled subgroup analysis of results from two DBPC trials. Allergy 2017;72:276-7.
Wahn 2009 {published data only}
    1. Wahn U, Bauer C, Agertoft L, Melac M, Le Gall M, Mqlac M, et al. Agreement of efficacy assessments for five grass pollen sublingual immunotherapy (SLIT) tablets in children and adolescents with grass pollen rhinoconjunctivitis and with or without mild asthma [Abstract]. Journal of Allergy and Clinical Immunology 2009;123:214.
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References to studies awaiting assessment

EUCTR2008‐03906‐32‐CZ {published data only}
    1. EUCTR2008-03906-32-CZ. A randomised, double-blind, placebo-controlled, multi national, phase III study of the efficacy and safety of 300 IR sublingual immunotherapy (SLIT), starting 2 months before the grass pollen season, administered as allergen based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis (with or without asthma). www.clinicaltrialsregister.eu/ctr-search/trial/2008-003906-32/CZ (first received 4 September 2008).
Hanna 2013a {published data only}
    1. Hanna K, Gohar H, Abdelkhalek Z, Sabry E, Oteba F. Sublingual immunotherapy: objective evaluation. Allergy, Asthma and Immunophysiology 2013:167-74.
Kozhem'iaka 1979 {published data only}
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Ma 2014 {published data only}
    1. Ma CX, Lu MF, Ge LP, Qian XM, Zhang MZ. Clinical evaluation of sublingual allergen specific immunotherapy in treatment to children with bronchial asthma and allergic rhinitis. Journal of Shanghai Jiaotong University (Medical Science) 2014;34(6):873-6.
Mantikou 2018 {published data only}
    1. Mantikou E, Couroux P, Salapatek A, Pfaar O, De KPJ, Narkus A, et al. Efficacy of SLIT with different doses of a liquid Phleum pratense extract was shown during the grass pollen season and in an Allergen Exposure Chamber (AEC). Allergy 2018;73:324.
    1. Mantikou E, Couroux P, Salapatek A, Pfaar O, Narkus A, Yu D, et al. Sublingual immunotherapy with a liquid Phleum pratense extract is effective in grass pollen allergic patients - results of a phase II allergen exposure chamber (AEC) trial. Allergy 2018;73:483.
    1. Mantikou E, Couroux P, Salapatek AM, Pfaar O, De KPJ, Yuet D, et al. Dose response and onset of action of sublingual immunotherapy with a liquid Phleum pratense extract in grass pollen allergic patients. Allergy 2018;73:321.
NCT00172341 {published data only}
    1. NCT00172341. Sublingual immunotherapy with house dust mite extract in asthmatic children. clinicaltrials.gov/ct2/show/NCT00172341 (first received 15 September 2005).
NCT00501527 {published data only}
    1. NCT00501527. Immunotherapy with depigmented and polymerized allergen extract of Phleum pratense. clinicaltrials.gov/ct2/show/NCT00501527 (first received 16 July 2007).
NCT00623701 {published data only}
    1. NCT00623701. Efficacy and safety from a high-dosed sublingual grass pollen preparation (ALLEGRA6). clinicaltrials.gov/ct2/show/NCT00623701 (first received 26 February 2006).
NCT00803244 {published data only}
    1. NCT00803244. Safety and efficacy on phase III study on 300 IR SLIT to patients suffering from grass pollen rhinoconjunctivitis (with or without asthma). clinicaltrials.gov/ct2/show/NCT00803244 (first received 25 May 2016).
NCT01052610 {published data only}
    1. NCT01052610. Assessment of sublingual immunotherapy in children allergic to house dust mites. clinicaltrials.gov/ct2/show/NCT01052610 (first received 20 January 2010).
NCT01529437 {published data only}
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NCT01603056 {published data only}
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NCT02478398 {published data only}
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Potter 2003 {published data only}
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References to ongoing studies

EUCTR2012‐005678‐76 {published data only}
    1. EUCTR2012-005678-76. Twenty-four month, multicenter, prospective, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy, safety, tolerability, and cost-effectiveness of allergen specific sublingual immunotherapy (SLIT) in combination with standard of care (SoC) in pediatric allergic asthma. www.clinicaltrialsregister.eu/ctr-search/search?query=2012-005678-76 (first received 30 August 2013).
Hassan 2010 {published data only}
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NCT01930461 {published data only}
    1. NCT01930461. Dose ranging study of SLIT tablets of house dust mite allergen extracts (HDM) in adults with HDM-associated allergic asthma. clinicaltrials.gov/ct2/show/NCT01930461 (first received 29 August 2013).
NCT02005627 {published data only}
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NCT02277483 {published data only}
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NCT03654976 {published data only}
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References to other published versions of this review

Normansell 2014a
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