The Effect of Ebastine/Pseudoephedrine on Subacute Cough

Not Applicable

• Conditions: Cough
• Interventions: Drug: Rhinoebastel; Drug: Placebo

• Registration Number: NCT02065440
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2011-09
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study First Submitted: 2014-02-16
• Study First Submitted QC: 2014-02-16
• Last Update Submitted: 2014-02-16
• Study First Posted: 2014-02-19
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• patients with subacute cough(3-8 weeks)
• age: 20-70 years

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ebastine/Pseudoephedrine	Rhinoebastel	administration of ebastine/pseudoephedrine 1cap/day for 1 week.
placebo	Placebo	administration of placebo pill 1 cap/day for 1week

Primary Outcome Measures

Name	Time	Method
Change of VAS score	1 week later after administration of ebastine/pseudoephedrine or placebo

Secondary Outcome Measures

Name	Time	Method
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	4 weeks later after administration of ebastine/pseudoephedrine or placebo
The adverse events	4 weeks

Trial Locations

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, Korea, Republic of