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

NCT04877678 | Completed Phase 4

• 1 other identifier: 2021-0363
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis; Cough

Keywords

cough, allergic rhinitis, antihistamines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Visual analogue scale (VAS) of cough

  At baseline, and at 2 weeks of treatment

• Cough hypersensitivity questionnaire (CHQ)

  At baseline, and at 2 weeks of treatment

• Sino-nasal outcome test -22 (SNOT-22)

  At baseline, and at 2 weeks of treatment

• Visual analogue scale (VAS) of globus pharyngeus

  At baseline, and at 2 weeks of treatment

• Daily cough severity

  daily assessment

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Participants will be treated with bepotastine.

Drug: Bepotastine

Placebo group

PLACEBO COMPARATOR

Participants will be treated with identical looking placebo.

Drug: Placebo

Interventions

Bepotastine DRUG

10 mg Bepotastine, twice a day

Also known as: Beposta B

Treatment group

Placebo DRUG

Identical looking placebo, twice a day

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \) 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)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan medical center

Seoul, South Korea

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Cough

Interventions

bepotastine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Woo-Jung Song

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation of medication is conducted by an independent physician who is not a co-investigator of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A Randomized, Double-blind, Placebo Controlled Study

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 31, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)