The Effect of Ebastine/Pseudoephedrine on Subacute Cough

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

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

Study Overview

• Status: Unknown
• Conditions: Cough
• Intervention / Treatment: Drug: Rhinoebastel; Drug: Placebo

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
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dongjak-Gu
    • Seoul, Dongjak-Gu, Korea, Republic of, 156-707
      • Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of VAS score	1 week later after administration of ebastine/pseudoephedrine or placebo

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• 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

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: February 16, 2014
• First Submitted That Met QC Criteria: February 16, 2014
• First Posted (Estimate): February 19, 2014

Study Record Updates

• Last Update Posted (Estimate): February 19, 2014
• Last Update Submitted That Met QC Criteria: February 16, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Ebastine/Pseudoephedrine; subacute cough; upper airway cough syndrome
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 06-2011-65