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

Primary Purpose

Allergic Rhinitis, Cough

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bepotastine
Placebo
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring cough, allergic rhinitis, antihistamines

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Asan medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment group

Placebo group

Arm Description

Participants will be treated with bepotastine.

Participants will be treated with identical looking placebo.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual analogue scale (VAS) of cough
The visual analogue scale of cough ranges from 0-100. A higher score indicates more severe cough.
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).
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.
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.
Daily cough severity
The scale of daily cough severity ranges from 0-10. A higher score indicates more severe cough.
Rate of adverse events
Rate of adverse events in participant
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.

Full Information

First Posted
May 4, 2021
Last Updated
January 3, 2023
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04877678
Brief Title
Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis
Official Title
Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis: A Randomized, Double-blind, Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Cough
Keywords
cough, allergic rhinitis, antihistamines

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A Randomized, Double-blind, Placebo Controlled Study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Allocation of medication is conducted by an independent physician who is not a co-investigator of the study.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
Participants will be treated with bepotastine.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Participants will be treated with identical looking placebo.
Intervention Type
Drug
Intervention Name(s)
Bepotastine
Other Intervention Name(s)
Beposta B
Intervention Description
10 mg Bepotastine, twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Identical looking placebo, twice a day
Primary Outcome Measure Information:
Title
Leicester Cough Questionnaire (LCQ)
Description
The total score range of Leicester Cough Questionnaire is from 3 to 21. A higher score indicates a better quality of life.
Time Frame
At baseline, and at 2 weeks of treatment
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS) of cough
Description
The visual analogue scale of cough ranges from 0-100. A higher score indicates more severe cough.
Time Frame
At baseline, and at 2 weeks of treatment
Title
Cough hypersensitivity questionnaire (CHQ)
Description
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).
Time Frame
At baseline, and at 2 weeks of treatment
Title
Sino-nasal outcome test -22 (SNOT-22)
Description
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.
Time Frame
At baseline, and at 2 weeks of treatment
Title
Visual analogue scale (VAS) of globus pharyngeus
Description
The visual analogue scale of globus pharyngeus ranges from 0-100. A higher score indicates more severe sensation of globus pharyngeus.
Time Frame
At baseline, and at 2 weeks of treatment
Title
Daily cough severity
Description
The scale of daily cough severity ranges from 0-10. A higher score indicates more severe cough.
Time Frame
daily assessment
Title
Rate of adverse events
Description
Rate of adverse events in participant
Time Frame
during 2 weeks of treatment
Title
Objective cough frequency
Description
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.
Time Frame
At baseline, and at 2 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo-Jung Song
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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