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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Stallergenes Greer
- Enrollment
- 355
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
100 IR
100 IR house dust mites allergen extract tablet
Intervention: 100 IR house dust mites allergen extract tablet (Drug)
300 IR
300 IR house dust mites allergen extract tablet
Intervention: 300 IR house dust mites allergen extract tablet (Drug)
500 IR
500 IR house dust mites allergen extract tablet
Intervention: 500 IR house dust mites allergen extract tablet (Drug)
Placebo
Placebo tablet
Intervention: Placebo tablet (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 6 months
The primary efficacy endpoint was the change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the four hours of the allergen challenge in the Environmental Exposure Chamber (EEC). The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale. The RTSS was evaluated every 15 minutes in the first 2 hours and every 30 minutes in the last two hours, i.e. at 13 timepoints during each allergen challenge (from T0 to T240), and the scores were plotted against time (0 to 4 hours) to calculate the area under the curve, AUCRTSS_0-4h. A decrease in the AUCRTSS_0-4h value represents relief from the HDM allergic symptoms.
Secondary Outcomes
- Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 2 Hours (2-4h) of the Allergen Challenge(6 months)