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

Phase 4

Completed

• Conditions: Allergic Rhinitis; Cough
• Interventions: Drug: Bepotastine; Drug: Placebo

• Registration Number: NCT04877678
• Lead Sponsor: Asan Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-07
• Study Start: 2021-10-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-10-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Had a cough for at least 3 weeks (score of ≥30 mm on the VAS)
2. 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)
3. Provided written informed consent
4. Were willing and able to comply with the study protocol

Exclusion Criteria

1. Current smoker or individuals who have smoked within the past 1 month prior to study entry
2. Sings of coexisting respiratory diseases requiring active treatment such as fever, chills, wheezing, dyspnea, or purulent sputum
3. Currently under allergen immunotherapy
4. 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
5. Treatment with an angiotensin converting enzyme (ACE)-inhibitor within 4 weeks prior to the enrollment
6. Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) < 0.7 or FEV1 % of predicted < 80% within 1 month prior to enrollment
7. Abnormal findings on chest x-ray related to cough within 1 month prior to enrollment
8. Diagnosis or treatment of bronchial asthma or COPD within 1 year of the enrollment
9. Clinically significant medical conditions possibly affecting evaluation of cough and nasal symptoms
10. History of hypersensitivity or severe adverse reaction to antihistamines
11. Unable to fill in the questionnaires (blindness, unable to read)
12. Unable to provide informed consent
13. History of taking following medication within 2 weeks of the enrollment; LTRA, nasal decongestants, intranasal corticosteroids (INS), systemic corticosteroids, antitussive agents (OTCs, codeine)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Bepotastine	Participants will be treated with bepotastine.
Placebo group	Placebo	Participants will be treated with identical looking placebo.

Primary Outcome Measures

Name	Time	Method
Leicester Cough Questionnaire (LCQ)	At baseline, and at 2 weeks of treatment	The total score range of Leicester Cough Questionnaire is from 3 to 21. A higher score indicates a better quality of life.

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) of cough	At baseline, and at 2 weeks of treatment	The visual analogue scale of cough ranges from 0-100. A higher score indicates more severe cough.
Cough hypersensitivity questionnaire (CHQ)	At baseline, and at 2 weeks of treatment	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).
Sino-nasal outcome test -22 (SNOT-22)	At baseline, and at 2 weeks of treatment	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.
Visual analogue scale (VAS) of globus pharyngeus	At baseline, and at 2 weeks of treatment	The visual analogue scale of globus pharyngeus ranges from 0-100. A higher score indicates more severe sensation of globus pharyngeus.
Daily cough severity	daily assessment	The scale of daily cough severity ranges from 0-10. A higher score indicates more severe cough.
Rate of adverse events	during 2 weeks of treatment	Rate of adverse events in participant
Objective cough frequency	At baseline, and at 2 weeks of treatment	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.

Trial Locations

Locations (1)

Asan medical center; 🇰🇷 Seoul, Korea, Republic of