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The Effect of Ebastine/Pseudoephedrine on Subacute Cough

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cough

Intervention: Rhinoebastel (Drug); Placebo (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Chang-Hoon Lee, MD, Study Chair, Affiliation: Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change of VAS score

Secondary outcome:

Change of VAS score

The proportion of patients with more than 50 percent decrease in VAS score

Change of CQLQ score

Change of CQLQ score

The adverse events

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

Eligibility

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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 and 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, Korea, Republic of
Additional Information

Starting date: September 2011
Last updated: February 16, 2014

Page last updated: August 20, 2015

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