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

NCT ID: NCT04877678

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-10-31

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.

Conditions

Allergic Rhinitis; Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment group

Participants will be treated with bepotastine.

Group Type: ACTIVE_COMPARATOR

Bepotastine

Intervention Type: DRUG

10 mg Bepotastine, twice a day

Placebo group

Participants will be treated with identical looking placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Identical looking placebo, twice a day

Interventions

Bepotastine

10 mg Bepotastine, twice a day

Intervention Type: DRUG

Placebo

Identical looking placebo, twice a day

Intervention Type: DRUG

Other Intervention Names

Beposta B

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Woo-Jung Song

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Woo-Jung Song

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan medical center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2021-0363

Identifier Type: -

Identifier Source: org_study_id