A Phase 4 interventional study of Bepotastine and Placebo in Allergic Rhinitis and Cough, sponsored by Asan Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by Asan Medical Center · Phase 4, Interventional, and Treatment
This is a phase 4 study to evaluate the the efficacy of second generation antihistamine on cough outcomes in cough patients with allergic rhinitis.
This is a randomized, double blind, placebo controlled trial in which a total of 78 participants who have cough (≥ 3 weeks) and symptoms of allergic rhinitis will be enrolled. Study participants will be randomly assigned to either active treatment or placebo group. The subjects in active treatment groups will be treated with daily oral bepotastine for 2 weeks, while those in placebo group will take identical-looking tablets. The efficacy of bepotastine will be assessed at the end of 2-week intervention using leicester cough questionnaire.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 50 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
Participants will be treated with bepotastine.
Drug: Bepotastine
Participants will be treated with identical looking placebo.
Drug: Placebo
10 mg Bepotastine, twice a day
Also known as: Beposta B
Identical looking placebo, twice a day
Leicester Cough Questionnaire (LCQ)
The total score range of Leicester Cough Questionnaire is from 3 to 21. A higher score indicates a better quality of life.
Time frame: At baseline, and at 2 weeks of treatment
Visual analogue scale (VAS) of cough
The visual analogue scale of cough ranges from 0-100. A higher score indicates more severe cough.
Time frame: At baseline, and at 2 weeks of treatment
Cough hypersensitivity questionnaire (CHQ)
The total score of cough hypersensitivity questionnaire ranges from 0-23. A higher score indicates a greater number of sensations or triggers associated with cough (or a higher degree of cough hypersensitivity).
Time frame: At baseline, and at 2 weeks of treatment
Sino-nasal outcome test -22 (SNOT-22)
The total score of sino-nasal outcome test -22 ranges from 0-110. A higher score indicates worse quality of life related to nasal symptoms.
Time frame: At baseline, and at 2 weeks of treatment
Visual analogue scale (VAS) of globus pharyngeus
The visual analogue scale of globus pharyngeus ranges from 0-100. A higher score indicates more severe sensation of globus pharyngeus.
Time frame: At baseline, and at 2 weeks of treatment
Daily cough severity
The scale of daily cough severity ranges from 0-10. A higher score indicates more severe cough.
Time frame: daily assessment
Rate of adverse events
Rate of adverse events in participant
Time frame: during 2 weeks of treatment
Objective cough frequency
24-hour objective cough frequency will be measured using the Hyfe Cough Tracker, a smartphone application-based cough monitoring. The measurement is optional and will be done in patients who agree to measure it.
Time frame: At baseline, and at 2 weeks of treatment
Plan to share: No
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Asan Medical Center