Status:
COMPLETED
Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis
Lead Sponsor:
Asan Medical Center
Conditions:
Allergic Rhinitis
Cough
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04877678
Start Date
October 1 2021
End Date
October 31 2022
Last Update
January 5 2023
Active Locations (1)
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1
Asan medical center
Seoul, South Korea