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

Phase 4
Completed
Conditions
Allergic Rhinitis
Cough
Interventions
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.

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
    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
  4. Treatment with an angiotensin converting enzyme (ACE)-inhibitor within 4 weeks prior to the enrollment
  5. Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) < 0.7 or FEV1 % of predicted < 80% within 1 month prior to enrollment
  6. Abnormal findings on chest x-ray related to cough within 1 month prior to enrollment
  7. Diagnosis or treatment of bronchial asthma or COPD within 1 year of the enrollment
  8. Clinically significant medical conditions possibly affecting evaluation of cough and nasal symptoms
  9. History of hypersensitivity or severe adverse reaction to antihistamines
  10. Unable to fill in the questionnaires (blindness, unable to read)
  11. Unable to provide informed consent
  12. 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
GroupInterventionDescription
Treatment groupBepotastineParticipants will be treated with bepotastine.
Placebo groupPlaceboParticipants will be treated with identical looking placebo.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Visual analogue scale (VAS) of coughAt 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 pharyngeusAt 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 severitydaily assessment

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

Rate of adverse eventsduring 2 weeks of treatment

Rate of adverse events in participant

Objective cough frequencyAt 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

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