Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis

Phase 3 Completed 574 enrolled Stallergenes Greer Aptuit · collab Cenduit LLC · collab PHT Corporation · collab Quintiles, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.

Timeline

Start: 2010-11
Primary completion: 2012-07
Completion: 2012-10

Outcome

Met primary endpoint

paper LS mean AAdSS was significantly lower in the 300IR group than in the placebo group (LS mean difference -2.04, 95% CI [-2.69, -1.40], (p <0.0001) PMID 24517417 ↗

Publications

Worm M, Rak S, de Blay F, Malling HJ, Melac M, Cadic V, Zeldin RK. Sustained efficacy and safety of a 300IR daily dose of a sublingual solution of birch pollen allergen extract in adults with allergic rhinoconjunctivitis: results of a double-blind, placebo-controlled study. Clin Transl Allergy. 2014 Feb 11;4(1):7. doi: 10.1186/2045-7022-4-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Birch pollen allergen extract	Unknown	300 unknown	Other