Allergic Rhinitis, Cough
Conditions
Keywords
cough, allergic rhinitis, antihistamines
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.
Interventions
DRUGBepotastine
10 mg Bepotastine, twice a day
DRUGPlacebo
Identical looking placebo, twice a day
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Allocation of medication is conducted by an independent physician who is not a co-investigator of the study.
Intervention model description
A Randomized, Double-blind, Placebo Controlled Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 pharyngeus | At 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. |
| Visual analogue scale (VAS) of cough | At baseline, and at 2 weeks of treatment | The visual analogue scale of cough ranges from 0-100. A higher score indicates more severe cough. |
| Rate of adverse events | during 2 weeks of treatment | Rate of adverse events in participant |
| Objective cough frequency | At 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. |
| Daily cough severity | daily assessment | The scale of daily cough severity ranges from 0-10. A higher score indicates more severe cough. |
Countries
South Korea
Outcome results
None listed