The Effect of Ebastine/Pseudoephedrine on Subacute Cough

NCT02065440 | Unknown DMC

• 1 other identifier: 06-2011-65
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cough

Keywords

Ebastine/Pseudoephedrine; subacute cough; upper airway cough syndrome

Outcome Measures

Primary Outcomes (1)

• Change of VAS score

  1 week later after administration of ebastine/pseudoephedrine or placebo

Secondary Outcomes (5)

• 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

Study Arms (2)

Ebastine/Pseudoephedrine

ACTIVE COMPARATOR

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

Drug: Rhinoebastel

placebo

PLACEBO COMPARATOR

administration of placebo pill 1 cap/day for 1week

Drug: Placebo

Interventions

Rhinoebastel DRUG

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

Ebastine/Pseudoephedrine

Placebo DRUG

Placebo 1 cap/day for 1 week unless progression or unacceptable toxicity develops

placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with subacute cough(3-8 weeks)
• age: 20-70 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

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

Seoul, Dongjak-Gu, 156-707, South Korea

Location

MeSH Terms

Conditions

Cough; upper airway cough syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2014
• First Posted: February 19, 2014
• Study Start: September 1, 2011
• Primary Completion: February 1, 2014
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

KR (1)