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Efficacy and Safety of Sublingual Immunotherapy for Allergic Rhinitis Due to House Dust Mites
Sponsor: Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.
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).
Official title: A Clinical Study on the Efficacy and Safety of Sublingual Film for Dermatophagoides Pteronyssinus in Chinese Adult Patients With Dust Mite Allergic Rhinitis - A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2026-03-23
Completion Date
2027-12-07
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Sublingual Film for Dermatophagoides pteronyssinus
In the first week, subjects received Sublingual Film for Dermatophagoides pteronyssinus at 15 BU. From the second week onward, subjects received the Sublingual Film for Dermatophagoides pteronyssinus at 150 BU until Week 52.
Sublingual Film for Dermatophagoides pteronyssinus
In the first week, subjects received Sublingual Film for Dermatophagoides pteronyssinus at 150 BU. From the second week onward, subjects received the Sublingual Film for Dermatophagoides pteronyssinus at 450 BU until Week 52.
Sublingual Film for Dermatophagoides pteronyssinus
In the first week, subjects received Sublingual Film for Dermatophagoides pteronyssinus at 450 BU. From the second week onward, subjects received the Sublingual Film for Dermatophagoides pteronyssinus at 1350 BU until Week 52
Sublingual Film for Dermatophagoides pteronyssinus
In the first week, subjects received Sublingual Film for Dermatophagoides pteronyssinus at 450 BU. In the second week, subjects received Sublingual Film for Dermatophagoides pteronyssinus at 1350 BU. From the third week onward, subjects received the Sublingual Film for Dermatophagoides pteronyssinus at 2700 BU until Week 52.
Sublingual Film for Dermatophagoides pteronyssinus placebo
Subjects receive a placebo(a look-alike substance that contains no drug) every day for 52 weeks
Locations (9)
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Hainan General Hospital
Haikou, Hainan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
Tongji Hospital, Tongji Medical College of Hust
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China