Cough
Conditions
Keywords
Ebastine/Pseudoephedrine, subacute cough, upper airway cough syndrome
Brief summary
To determine whether ebastine/pseudoephedrine is effective on subacute cough.
Detailed description
1. Visit 0 week * Patients with subacute cough,area randomized to either ebastine/pseudoephedrine or placebo for 1 week. * The cough severity and quality of life were measure with VAS score and cough-specific quality-of-life questionnaire(CQLQ) 2. Visit 1 week check VAS score and CQLQ 3. Visit 4 weeks check VAS score and CQLQ
Interventions
DRUGRhinoebastel
Rhinoebastel(ebastine 10mg/pseudoephedrine 120mg) 1 cap/day for 1 week unless progression or unacceptable toxicity develops.
DRUGPlacebo
Placebo 1 cap/day for 1 week unless progression or unacceptable toxicity develops
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patients with subacute cough(3-8 weeks) * age: 20-70 years
Exclusion criteria
* Chest X-ray abnormality(+) as a probable cause of cough * other explainable confirmed diagnosis(+) such as acute infectious disease * Severe cough or cough complication which needs other anti-tussive agents. * on ACEI * with more than three hypertensive agents * change of hypertension medication 3 months ago * immunocompromized host * relative or absolute contraindication for ebastine/pseudoephedrine 1. hypersensitivity to ebastine/pseudoephedrine 2. glaucoma 3. moderate to severe hypertensive disease 4. coronary heart disease 5. hyperthyroidism 6. moderate to severe liver disease 7. benign prostate hyperplasia 8. psychological problem 9. Parkinson's disease 10. on linezolid or supposed to use it.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of VAS score | 1 week later after administration of ebastine/pseudoephedrine or placebo |
Secondary
| Measure | Time frame |
|---|---|
| Change of VAS score | 4 weeks later after administration of ebastine/pseudoephedrine or placebo |
| The proportion of patients with more than 50 percent decrease in VAS score | 1 week |
| Change of CQLQ score | 1week later after administration of ebastine/pseudoephedrine or placebo |
| The adverse events | 4 weeks |
Countries
South Korea
Outcome results
None listed