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The Effect of Ebastine/Pseudoephedrine on Subacute Cough

Primary Purpose

Cough

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rhinoebastel
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough focused on measuring Ebastine/Pseudoephedrine, subacute cough, upper airway cough syndrome

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ebastine/Pseudoephedrine

placebo

Arm Description

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

administration of placebo pill 1 cap/day for 1week

Outcomes

Primary Outcome Measures

Change of VAS score

Secondary Outcome Measures

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

Full Information

First Posted
February 16, 2014
Last Updated
February 16, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02065440
Brief Title
The Effect of Ebastine/Pseudoephedrine on Subacute Cough
Official Title
The Effect of Ebastine/Pseudoephedrine on Subacute Cough :a Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine whether ebastine/pseudoephedrine is effective on subacute cough.
Detailed Description
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) Visit 1 week check VAS score and CQLQ Visit 4 weeks check VAS score and CQLQ

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
Ebastine/Pseudoephedrine, subacute cough, upper airway cough syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ebastine/Pseudoephedrine
Arm Type
Active Comparator
Arm Description
administration of ebastine/pseudoephedrine 1cap/day for 1 week.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
administration of placebo pill 1 cap/day for 1week
Intervention Type
Drug
Intervention Name(s)
Rhinoebastel
Intervention Description
Rhinoebastel(ebastine 10mg/pseudoephedrine 120mg) 1 cap/day for 1 week unless progression or unacceptable toxicity develops.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1 cap/day for 1 week unless progression or unacceptable toxicity develops
Primary Outcome Measure Information:
Title
Change of VAS score
Time Frame
1 week later after administration of ebastine/pseudoephedrine or placebo
Secondary Outcome Measure Information:
Title
Change of VAS score
Time Frame
4 weeks later after administration of ebastine/pseudoephedrine or placebo
Title
The proportion of patients with more than 50 percent decrease in VAS score
Time Frame
1 week
Title
Change of CQLQ score
Time Frame
1week later after administration of ebastine/pseudoephedrine or placebo
Title
Change of CQLQ score
Time Frame
4 weeks later after administration of ebastine/pseudoephedrine or placebo
Title
The adverse events
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 hypersensitivity to ebastine/pseudoephedrine glaucoma moderate to severe hypertensive disease coronary heart disease hyperthyroidism moderate to severe liver disease benign prostate hyperplasia psychological problem Parkinson's disease on linezolid or supposed to use it.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Hoon Lee, MD
Organizational Affiliation
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
City
Seoul
State/Province
Dongjak-Gu
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

The Effect of Ebastine/Pseudoephedrine on Subacute Cough

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