Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis: A Randomized, Double-blind, Placebo Controlled Study

Conditions
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Allergic Rhinitis, Cough

Intervention / Treatment
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* Drug: Bepotastine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Had a cough for at least 3 weeks (score of ≥30 mm on the VAS) History or allergic rhinitis confirmed with skin prick test or serum specific IgE test AND current one or more symptoms of allergic rhinitis (runny nose, obstruction, sneezing, nasal itching) Provided written informed consent Were willing and able to comply with the study protocol Exclusion Criteria: Current smoker or individuals who have smoked within the past 1 month prior to study entry Sings of coexisting respiratory diseases requiring active treatment such as fever, chills, wheezing, dyspnea, or purulent sputum Currently under allergen immunotherapy 1) Allergic rhinitis or chronic rhinosinusitis under treatment with intranasal corticosteroids (INS) or leukotriene receptor antagonist (LTRA) or 2) allergic rhinitis requiring treatment with INS or LTRA Treatment with an angiotensin converting enzyme (ACE)-inhibitor within 4 weeks prior to the enrollment Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) < 0.7 or FEV1 % of predicted < 80% within 1 month prior to enrollment Abnormal findings on chest x-ray related to cough within 1 month prior to enrollment Diagnosis or treatment of bronchial asthma or COPD within 1 year of the enrollment Clinically significant medical conditions possibly affecting evaluation of cough and nasal symptoms History of hypersensitivity or severe adverse reaction to antihistamines Unable to fill in the questionnaires (blindness, unable to read) Unable to provide informed consent History of taking following medication within 2 weeks of the enrollment; LTRA, nasal decongestants, intranasal corticosteroids (INS), systemic corticosteroids, antitussive agents (OTCs, codeine)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized, Double-blind, Placebo Controlled Study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Participants will be treated with bepotastine. | Drug: Bepotastine<br>* 10 mg Bepotastine, twice a day<br>* Other names: Beposta B;|
| Placebo Comparator: Placebo group<br>Participants will be treated with identical looking placebo. | Drug: Placebo<br>* Identical looking placebo, twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cough, allergic rhinitis, antihistamines