The Effect of Ebastine/Pseudoephedrine on Subacute Cough

• ClinicalTrials.gov Identifier: NCT02065440
• Recruitment Status: Unknown
• First Posted: February 19, 2014
• Last Update Posted: February 19, 2014
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Seoul National University Hospital

Tracking Information

• First Submitted Date: February 16, 2014
• First Posted Date: February 19, 2014
• Last Update Posted Date: February 19, 2014
• Study Start Date: September 2011
• Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 16, 2014): Change of VAS score [ Time Frame: 1 week later after administration of ebastine/pseudoephedrine or placebo ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 16, 2014)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Cough

Intervention

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

Study Arms

• Active Comparator: Ebastine/Pseudoephedrine
  administration of ebastine/pseudoephedrine 1cap/day for 1 week.
  Intervention: Drug: Rhinoebastel
• Placebo Comparator: placebo
  administration of placebo pill 1 cap/day for 1week
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 16, 2014): 130
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

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

  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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02065440
• Other Study ID Numbers: 06-2011-65
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Seoul National University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Seoul National University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: Seoul National University Hospital
• Verification Date: February 2014