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

• Sponsor: Asan Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04877678
• Collaborator: (none)
• Enrollment: 78
• Arms: 2
• Anticipated Duration (Months): 14

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis; Cough	Drug: Bepotastine; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A Randomized, Double-blind, Placebo Controlled StudyA Randomized, Double-blind, Placebo Controlled Study
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Allocation of medication is conducted by an independent physician who is not a co-investigator of the study.
• Primary Purpose: Treatment
• Official Title: Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis: A Randomized, Double-blind, Placebo Controlled Study
• Anticipated Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment group Participants will be treated with bepotastine.	Drug: Bepotastine; 10 mg Bepotastine, twice a day; Other Names: Beposta B
Placebo Comparator: Placebo group Participants will be treated with identical looking placebo.	Drug: Placebo; Identical looking placebo, twice a day

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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).

3. 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.

4. 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.

5. Daily cough severity [daily assessment]

   The scale of daily cough severity ranges from 0-10. A higher score indicates more severe cough.

6. Rate of adverse events [during 2 weeks of treatment]

   Rate of adverse events in participant

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Asan Medical Center

Investigators

• Principal Investigator: Woo-Jung Song, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Woo-Jung Song, Professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT04877678
• Other Study ID Numbers: 2021-0363
• First Posted: May 7, 2021
• Last Update Posted: Oct 27, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Woo-Jung Song, Professor, Asan Medical Center: cough, allergic rhinitis, antihistamines
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Cough; Bepotastine besilate

Study Results

No Results Posted as of Oct 27, 2021