Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis

Phase 3 Completed 473 enrolled Stallergenes Greer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.

Timeline

Start: 2008-10
Primary completion: 2009-08
Completion: 2009-08

Outcome

Met primary endpoint

paper The mean daily CS over the pollen period was significantly lower in the active treatment group versus the placebo group PMID 23122534 ↗

registry analysis (superiority or other test); 300 IR vs Placebo; p = 0.0003; LS Mean difference vs. Placebo -0.126 (95% CI -0.194 to -0.058); ANCOVA NCT00955825 ↗

Publications

Results Cox LS, Casale TB, Nayak AS, Bernstein DI, Creticos PS, Ambroisine L, Melac M, Zeldin RK. Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE. J Allergy Clin Immunol. 2012 Dec;130(6):1327-34.e1. doi: 10.1016/j.jaci.2012.08.032. Epub 2012 Oct 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	300 IR	Unknown	300 unknown	Other