NCT01527188

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

A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase II Study to Assess the Efficacy and Safety of 100IR, 300IR and 500IR Sublingual Tablets of House Dust Mite Allergen for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Stallergenes Greer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Rhinitis Due to House Dust Mite

Interventions

Type	Name	Description
DRUG	100 IR house dust mites allergen extract tablet	One sublingual tablet daily during 6 months
DRUG	300 IR house dust mites allergen extract tablet	One sublingual tablet daily during 6 months
DRUG	500 IR house dust mites allergen extract tablet	One sublingual tablet daily during 6 months
DRUG	Placebo tablet	One sublingual tablet daily during 6 months

Timeline

• Start date: 2010-12-08
• Primary completion: 2012-03-01
• Completion: 2012-09-19
• First posted: 2012-02-06
• Last updated: 2025-02-04
• Results posted: 2025-02-04

Locations

1 site across 1 country: Canada