Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

Phase 3 Completed 278 enrolled Stallergenes Greer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.

Timeline

Start: 2006-12
Primary completion: 2007-09
Completion: 2007-09

Outcome

Met primary endpoint

registry analysis (superiority or other test); 300 IR vs Placebo; p = 0.0010; ANCOVA NCT00409409 ↗

Publications

Results Wahn U, Tabar A, Kuna P, Halken S, Montagut A, de Beaumont O, Le Gall M; SLIT Study Group. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2009 Jan;123(1):160-166.e3. doi: 10.1016/j.jaci.2008.10.009. Epub 2008 Nov 29.

Drugs

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