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To determine whether ebastine/pseudoephedrine is effective on subacute cough.
Visit 0 week
Visit 1 week check VAS score and CQLQ
Visit 4 weeks check VAS score and CQLQ
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ebastine/Pseudoephedrine | Active Comparator | administration of ebastine/pseudoephedrine 1cap/day for 1 week. |
|
| placebo | Placebo Comparator | administration of placebo pill 1 cap/day for 1week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhinoebastel | Drug | Rhinoebastel(ebastine 10mg/pseudoephedrine 120mg) 1 cap/day for 1 week unless progression or unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of VAS score | 1 week later after administration of ebastine/pseudoephedrine or placebo |
| 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 | |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Hoon Lee, MD | Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center | Seoul | Dongjak-Gu | 156-707 | South Korea |
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| ID | Term |
|---|---|
| D003371 | Cough |
| C000726767 | upper airway cough syndrome |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Placebo | Drug | Placebo 1 cap/day for 1 week unless progression or unacceptable toxicity develops |
|
| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |