The Effect of Ebastine/Pseudoephedrine on Subacute Cough

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02065440
• Other study ID #: 06-2011-65
• Status: Active, not recruiting
• Phase: N/A
• First received: February 16, 2014
• Last updated: February 16, 2014
• Start date: September 2011

Study information

• Verified date: February 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cough

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center	Seoul	Dongjak-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of VAS score		1 week later after administration of ebastine/pseudoephedrine or placebo	No
Secondary	Change of VAS score		4 weeks later after administration of ebastine/pseudoephedrine or placebo	No
Secondary	The proportion of patients with more than 50 percent decrease in VAS score		1 week	No
Secondary	Change of CQLQ score		1week later after administration of ebastine/pseudoephedrine or placebo	No
Secondary	Change of CQLQ score		4 weeks later after administration of ebastine/pseudoephedrine or placebo	No
Secondary	The adverse events		4 weeks	Yes