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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
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.
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.
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
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.
Subjects receive a placebo(a look-alike substance that contains no drug) every day for 52 weeks
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
daily combined scores of rhinitis symptoms and medication
the daily combined scores of medication and rhinitis symptoms (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 4 rhinitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing) and the daily rescue medication score. Higher scores indicate more severe symptoms and a worse outcome.
Time frame: Week 49-52
daily combined scores of rhinitis symptoms and medication
the daily combined scores of medication and rhinitis symptoms (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 4 rhinitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing) and the daily rescue medication score. Higher scores indicate more severe symptoms and a worse outcome.
Time frame: Week 13-16; Week 25-28; Week 37-40
daily total nasal symptom score
daily total nasal symptom score was the sum of four nasal symptom scores for nasal congestion, discharge, itching and sneezing (ranging from 0 to 12). Nasal symptoms were rated on a 4-point scale, while 0 = no symptoms, 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping)
Time frame: Week 13-16; Week 25-28; Week 37-40; Week 49-52
daily Rescue Medication Scores
daily Rescue Medication Scores is the rescue medication score in each day (ranging from 0 to 3). 0 = no rescue medication uses, 1 = Oral and/or topical non-sedative H1 antihistamines, 2 = Intranasal corticosteroids (Rhinocort) with/without H1 antihistamines, and 3 = Oral corticosteroids with/without intranasal corticosteroids, with/without H1 antihistamines.
Time frame: Week 13-16; Week 25-28; Week 37-40; Week 49-52
daily combined scores of medication and rhinoconjunctivitis symptoms
the daily combined scores of medication and rhinoconjunctivitis symptoms (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 6 rhinoconjunctivitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing, ocular pruritus, and watery eyes) and the daily rescue medication score. Higher scores indicate more severe symptoms and a worse outcome.
Time frame: Week 13-16; Week 25-28; Week 37-40; Week 49-52
adverse event
Time frame: Week 1-52
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