The Effect of Ebastine/Pseudoephedrine on Subacute Cough

Study Overview
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Brief Summary
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To determine whether ebastine/pseudoephedrine is effective on subacute cough.

Detailed Description
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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) Visit 1 week check VAS score and CQLQ Visit 4 weeks check VAS score and CQLQ

Official Title
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The Effect of Ebastine/Pseudoephedrine on Subacute Cough :a Randomized Placebo-controlled Trial

Conditions
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Cough

Intervention / Treatment
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* Drug: Rhinoebastel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 hypersensitivity to ebastine/pseudoephedrine glaucoma moderate to severe hypertensive disease coronary heart disease hyperthyroidism moderate to severe liver disease benign prostate hyperplasia psychological problem Parkinson's disease on linezolid or supposed to use it.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ebastine/Pseudoephedrine<br>administration of ebastine/pseudoephedrine 1cap/day for 1 week. | Drug: Rhinoebastel<br>* Rhinoebastel(ebastine 10mg/pseudoephedrine 120mg) 1 cap/day for 1 week unless progression or unacceptable toxicity develops.<br>|
| Placebo Comparator: placebo<br>administration of placebo pill 1 cap/day for 1week | Drug: Placebo<br>* Placebo 1 cap/day for 1 week unless progression or unacceptable toxicity develops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of VAS score |  | 1 week later after administration of ebastine/pseudoephedrine or placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Change of CQLQ score |  | 4 weeks later after administration of ebastine/pseudoephedrine or placebo | 
| The adverse events |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ebastine/Pseudoephedrine, subacute cough, upper airway cough syndrome