Efficacy and Safety of Sublingual Immunotherapy for Allergic Rhinitis Due to House Dust Mites (NCT07475715) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of Sublingual Immunotherapy for Allergic Rhinitis Due to House Dust Mites
China250 participantsStarted 2026-03-23
Plain-language summary
To evaluate the efficacy and safety of different doses of Sublingual Film for Dermatophagoides Pteronyssinus in adult patients with Dust Mite Allergic Rhinitis via a randomized, double-blind, placebo-controlled Phase II clinical trial, and to explore the optimal dose for the Phase III clinical trial.
This study consisted of 5 groups, including 4 treatment groups with different doses and 1 placebo group.
Subjects used Sublingual Film for Dermatophagoides pteronyssinus or a placebo (a look-alike substance that contains no drug) for approximately 52 weeks, and recorded in E-diary the usage of the investigational product, adverse events, concomitant medications, and the use of rescue medication.
Four efficacy data collection periods (each lasting 4 weeks) were scheduled during the trial: Week 13-16, Week 25-28, Week 37-40, and Week 49-52.
During these efficacy data collection periods, subjects were required to complete E-diary to record rhinitis symptoms (conjunctivitis symptoms were recorded simultaneously for subjects with concurrent conjunctivitis).
Who can participate
Age range18 Years ā 60 Years
SexALL
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Inclusion Criteria:
* Aged between 18 and 60 (including 18 and 60), male or female;
* Diagnosed with allergic rhinitis (documented by medical records/prescriptions/specific IgE test reports for allergens, etc.) for ā„ 6 months prior to screening;
* Skin Prick Test (SPT) during screening shows a maximum wheal diameter of ā„ 5 mm for Dermatophagoides pteronyssinus;
* Dermatophagoides pteronyssinus (or mite mix containing Dermatophagoides pteronyssinus) specific immunoglobulin E (IgE) levels of class 3 or higher during screening;
* Pulmonary function test (routine spirometry) during screening shows FEVā % predicted ā„ 70%;
* Total daily nasal symptom score ā„ 6 for at least 5 days out of the last consecutive 10 days within the 14 days prior to randomization;
* Use of symptomatic medication for allergic rhinitis on at least 5 days out of the last consecutive 10 days within the 14 days prior to randomization;
* Subjects have fully understood the purpose, nature, methods and potential adverse reactions of the trial, voluntarily participate in this clinical trial, and are able to provide written informed consent prior to initiation of any study procedures;
* Subjects are able to communicate well with the investigators and understand and comply with all requirements of this clinical trial.
Exclusion Criteria:
* Subjects have a history of seasonal allergic rhinitis, and the onset season may overlap with the baseline or primary efficacy data collection period;
* Subjects have a serum spā¦
What they're measuring
1
daily combined scores of rhinitis symptoms and medication