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The Effect of Ebastine/Pseudoephedrine on Subacute Cough

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ClinicalTrials.gov Identifier: NCT02065440
Recruitment Status : Unknown
Verified February 2014 by Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 19, 2014
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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Brief Summary:
To determine whether ebastine/pseudoephedrine is effective on subacute cough.

Condition or disease Intervention/treatment Phase
Cough Drug: Rhinoebastel Drug: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Ebastine/Pseudoephedrine on Subacute Cough :a Randomized Placebo-controlled Trial
Study Start Date : September 2011
Estimated Primary Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ebastine/Pseudoephedrine
administration of ebastine/pseudoephedrine 1cap/day for 1 week.
 Drug: Rhinoebastel
Rhinoebastel(ebastine 10mg/pseudoephedrine 120mg) 1 cap/day for 1 week unless progression or unacceptable toxicity develops.
Placebo Comparator: placebo
administration of placebo pill 1 cap/day for 1week
 Drug: Placebo
Placebo 1 cap/day for 1 week unless progression or unacceptable toxicity develops


Outcome Measures
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Primary Outcome Measures :
  1. Change of VAS score [ Time Frame: 1 week later after administration of ebastine/pseudoephedrine or placebo ]

Secondary Outcome Measures :
  1. Change of VAS score [ Time Frame: 4 weeks later after administration of ebastine/pseudoephedrine or placebo ]
  2. The proportion of patients with more than 50 percent decrease in VAS score [ Time Frame: 1 week ]
  3. Change of CQLQ score [ Time Frame: 1week later after administration of ebastine/pseudoephedrine or placebo ]
  4. Change of CQLQ score [ Time Frame: 4 weeks later after administration of ebastine/pseudoephedrine or placebo ]
  5. The adverse events [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065440


Locations
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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, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: Chang-Hoon Lee, MD Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
More Information
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02065440    
Other Study ID Numbers: 06-2011-65
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014
Keywords provided by Seoul National University Hospital:
Ebastine/Pseudoephedrine
subacute cough
upper airway cough syndrome
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory