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

NCT01527188 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2025-02-04

Study results available
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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

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

Sponsors & Collaborators

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Peter Couroux, MD, FRCPC · Cetero Research / PRACS Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-08
Primary Completion
2012-03-31
Completion
2012-09-19

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01527188 on ClinicalTrials.gov