The Effect of Ebastine/Pseudoephedrine on Subacute Cough

N/AUnknownNCT02065440

Seoul National University Hospital130 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

130

Conditions

Cough

Interventions

RhinoebastelDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Seoul, Dongjak-Gu, South Korea

Outcomes

Primary Outcomes

Change of VAS score

Time frame: 1 week later after administration of ebastine/pseudoephedrine or placebo

Secondary Outcomes

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

Data from ClinicalTrials.gov

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