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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | Participants will be treated with bepotastine. |
|
| Placebo group | Placebo Comparator | Participants will be treated with identical looking placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepotastine | Drug | 10 mg Bepotastine, twice a day |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, and at 2 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale (VAS) of cough | The visual analogue scale of cough ranges from 0-100. A higher score indicates more severe cough. | At baseline, and at 2 weeks of treatment |
| Cough hypersensitivity questionnaire (CHQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Woo-Jung Song | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan medical center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D003371 | Cough |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C108476 | bepotastine |
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A Randomized, Double-blind, Placebo Controlled Study
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Allocation of medication is conducted by an independent physician who is not a co-investigator of the study.
| Placebo | Drug | Identical looking placebo, twice a day |
|
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).
| 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. | 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. | 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. | daily assessment |
| Rate of adverse events | Rate of adverse events in participant | 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. | At baseline, and at 2 weeks of treatment |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |