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 range
18 Years – 60 Years
Sex
ALL
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:
* 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 ≥ 6 months prior to screening;
* Skin Prick Test (SPT) during screening shows a maximum wheal diameter of ≥ 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 FEV₁ % predicted ≥ 70%;
* Total daily nasal symptom score ≥ 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 sp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
daily combined scores of rhinitis symptoms and medication