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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Bepotastine besilate

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)