Overview

This trial is active, not recruiting.

Condition cough
Treatments rhinoebastel, placebo
Sponsor Seoul National University Hospital
Start date September 2011
End date February 2014
Trial size 130 participants
Trial identifier NCT02065440, 06-2011-65

Summary

To determine whether ebastine/pseudoephedrine is effective on subacute cough.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
administration of ebastine/pseudoephedrine 1cap/day for 1 week.
rhinoebastel
Rhinoebastel(ebastine 10mg/pseudoephedrine 120mg) 1 cap/day for 1 week unless progression or unacceptable toxicity develops.
(Placebo Comparator)
administration of placebo pill 1 cap/day for 1week
placebo
Placebo 1 cap/day for 1 week unless progression or unacceptable toxicity develops

Primary Outcomes

Measure
Change of VAS score
time frame: 1 week later after administration of ebastine/pseudoephedrine or placebo

Secondary Outcomes

Measure
Change of VAS score
time frame: 4 weeks later after administration of ebastine/pseudoephedrine or placebo
The proportion of patients with more than 50 percent decrease in VAS score
time frame: 1 week
Change of CQLQ score
time frame: 1week later after administration of ebastine/pseudoephedrine or placebo
Change of CQLQ score
time frame: 4 weeks later after administration of ebastine/pseudoephedrine or placebo
The adverse events
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

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.

Additional Information

Official title The Effect of Ebastine/Pseudoephedrine on Subacute Cough :a Randomized Placebo-controlled Trial
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.