Phase 2
Completed 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
Source: ClinicalTrials.gov NCT01527188 ↗
Enrolled (actual)
355
Serious AEs
1.1%
Results posted
Feb 2025
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.