Member of Global Allergy and Asthma European Network (GA2LEN), supported by the EU Framework programme for research, contract no. FOOD-CT-2004-506378.
How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA2LEN statement
Version of Record online: 18 APR 2011
© 2011 John Wiley & Sons A/S
Volume 66, Issue 6, pages 765–774, June 2011
How to Cite
Bousquet, J., Schünemann, H. J., Bousquet, P. J., Bachert, C., Canonica, G. W., Casale, T. B., Demoly, P., Durham, S., Carlsen, K.-H., Malling, H.-J., Passalacqua, G., Simons, F. E. R., Anto, J., Baena-Cagnani, C. E., Bergmann, K.-C., Bieber, T., Briggs, A. H., Brozek, J., Calderon, M. A., Dahl, R., Devillier, P., Gerth van Wijk, R., Howarth, P., Larenas, D., Papadopoulos, N. G., Schmid-Grendelmeier, P. and Zuberbier, T. (2011), How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA2LEN statement. Allergy, 66: 765–774. doi: 10.1111/j.1398-9995.2011.02590.x
Edited by: Hans-Uwe Simon
- Issue online: 26 APR 2011
- Version of Record online: 18 APR 2011
- Accepted for publication 10 March 2011
- randomized controlled trials;
- symptom score
To cite this article: Bousquet J, Schünemann HJ, Bousquet PJ, Bachert C, Canonica GW, Casale TB, Demoly P, Durham S, Carlsen K-H, Malling H-J, Passalacqua G, Simons FER, Anto J, Baena-Cagnani CE, Bergmann K-C, Bieber T, Briggs AH, Brozek J, Calderon MA, Dahl R, Devillier P, Gerth van Wijk R, Howarth P, Larenas D, Papadopoulos NG, Schmid-Grendelmeier P, Zuberbier T. How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA2LEN statement. Allergy 2011; 66: 765–774.
Specific immunotherapy (SIT) is one of the treatments for allergic rhinitis. However, for allergists, nonspecialists, regulators, payers, and patients, there remain gaps in understanding the evaluation of randomized controlled trials (RCTs). Although treating the same diseases, RCTs in SIT and pharmacotherapy should be considered separately for several reasons, as developed in this study. These include the severity and persistence of allergic rhinitis in the patients enrolled in the study, the problem of the placebo, allergen exposure (in particular pollen and mite), the analysis and reporting of the study, the level of symptoms of placebo-treated patients, the clinical relevance of the efficacy of SIT, the need for a validated combined symptom–medication score, the differences between children and adults and pharmacoeconomic analyses. This statement reviews issues raised by the interpretation of RCTs in sublingual immunotherapy. It is not possible to directly extrapolate the rules or parameters used in medication RCTs to SIT. It also provides some suggestions for the research that will be needed. Interestingly, some of the research questions can be approached with the available data obtained from large RCTs.