Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite Tablets in Allergic Rhinitis Environment Exposure Chamber Model

Phase 2 Completed 355 enrolled Stallergenes Greer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score during the allergen chamber challenge before and after 6 months of treatment.

Timeline

Start: 2010-12-08
Primary completion: 2012-03
Completion: 2012-09-19

Outcome

Met primary endpoint

registry 500 IR vs Placebo; p = 0.0427; Difference in LS Means -198.18 (95% CI -389.82 to -6.55); ANCOVA NCT01527188 ↗

Publications

Worm M, Demoly P, Okamoto Y, Vidal C, Daghildjian K, Yan K, Casale TB, Bergmann KC. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	house dust mites allergen extract	Other / unclassified	100 unknown	Other
Subject	house dust mites allergen extract	Other / unclassified	300 unknown	Other
Subject	house dust mites allergen extract	Other / unclassified	500 unknown	Other