The Effect of Ebastine/Pseudoephedrine on Subacute Cough

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ebastine/Pseudoephedrine

administration of ebastine/pseudoephedrine 1cap/day for 1 week.

Group Type ACTIVE_COMPARATOR

Rhinoebastel

Intervention Type DRUG

Rhinoebastel(ebastine 10mg/pseudoephedrine 120mg) 1 cap/day for 1 week unless progression or unacceptable toxicity develops.

placebo

administration of placebo pill 1 cap/day for 1week

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1 cap/day for 1 week unless progression or unacceptable toxicity develops

Interventions

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Rhinoebastel

Rhinoebastel(ebastine 10mg/pseudoephedrine 120mg) 1 cap/day for 1 week unless progression or unacceptable toxicity develops.

Intervention Type DRUG

Placebo

Placebo 1 cap/day for 1 week unless progression or unacceptable toxicity develops

Intervention Type DRUG

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

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chang-Hoon Lee, MD

Role: STUDY_CHAIR

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center