CompletedPhase 2

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

Canada355 participantsStarted 2010-12-08

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * history of HDM rhinitis allergy for \> 1 year * sensitized to D. pteronyssinus and/or D. farinae * RTSS \>= 6 at least 2 time points during allergen challenge session Exclusion Criteria: * co sensitization to other allergen than HDM * FEV1 \< 80% * Asthma GINA \> 1

What they're measuring

Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 4 Hours (0-4h) of the Allergen Challenge

Timeframe: 6 months

Trial details

NCT IDNCT01527188

SponsorStallergenes Greer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-03

Results submitted2024-11-27

View on ClinicalTrials.gov More Allergic Rhinitis Due to House Dust Mite trials