Phase 2
N=355
Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite Tablets in Allergic Rhinitis Environment Exposure Chamber Model
Allergic Rhinitis Due to House Dust Mite
Bottom Line
View on ClinicalTrials.gov: NCT01527188 ↗Enrolled (actual)
355
Serious AEs
1.1%
Results posted
Feb 2025
Primary outcome: Primary: 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 — -715.83; -769.21; -795.58; -597.40 RTSS * hour — p=0.0427
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 100 IR house dust mites allergen extract tablet (Drug); 300 IR house dust mites allergen extract tablet (Drug); 500 IR house dust mites allergen extract tablet (Drug); Placebo tablet (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stallergenes Greer
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-715.83; -769.21; -795.58; -597.40 | 0.0427 sig |
| SECONDARY 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 |
-390.34; -421.39; -424.77; -299.16 | 0.0323 sig |
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.
Eligibility Criteria
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 1
Data sourced from ClinicalTrials.gov (NCT01527188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.