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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877678
• Other study ID #: 2021-0363
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: January 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Allergic Rhinitis
• Cough
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Bepotastine
10 mg Bepotastine, twice a day
• Placebo
Identical looking placebo, twice a day

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Daily cough severity	The scale of daily cough severity ranges from 0-10. A higher score indicates more severe cough.	daily assessment
Secondary	Rate of adverse events	Rate of adverse events in participant	during 2 weeks of treatment
Secondary	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