The Effect of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity - Full Text View

The Effect of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity (montelukast)

This study is currently recruiting participants.

Verified by Isala Klinieken, March 2009

First Received: March 28, 2007 Last Updated: March 25, 2009 History of Changes

Sponsor:	Isala Klinieken
Information provided by:	Isala Klinieken
ClinicalTrials.gov Identifier:	NCT00453765

Purpose

The purpose is to determine whether montelukast during 6 weeks has superior antitussive effects (measured with the LCQ) compared with placebo in patients with cough lasting > 8 weeks and enhanced bronchial hyperreactivity.

Condition	Intervention	Phase
Cough Bronchial Hyperreactivity	Drug: montelukast Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective Single-Centre, Double Blind Randomised Trial of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity

Resource links provided by NLM:

MedlinePlus related topics: Cough

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Isala Klinieken:

Primary Outcome Measures:

Difference in average score on the Leicester Cough Questionnaire (LCQ) between the two treatment groups; montelukast vs placebo. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Difference in cough VAS scores; montelukast vs placebo. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Comparison of the adverse events of montelukast vs placebo. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental montelukast	Drug: montelukast montelukast, 8 weeks, once daily, 10 milligrams
B: Placebo Comparator placebo	Drug: placebo placebo

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients between 18 and 90 years old, referred to the cough outpatient clinic with chronic cough and enhanced bronchial hyperreactivity.
chronic cough is defined as a cough > 8 weeks duration.
enhanced bronchial hyperreactivity is a PD20 < 2.5 mg methacholine.

Exclusion Criteria:

concomitant severe disease; lung cancer and diseases with a short life expectancy (< 1 year).
patients suffering from COPD and/or other relevant lung diseases.
clinically relevant abnormal laboratory values suggesting an unknown disease requiring further clinical evaluation.
use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 courses during the last 6 months.
pregnancy.
abnormal chest X-ray.
use of medication inducing CYP3A4 (for example; fenytoïne, phenobarbital or rifampicin.
use of medication metabolised by CYP2C8.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453765

Contacts

Contact: Jan Willem Van Den Berg, MD	+31 38 4242000 ext 4474	j.w.k.van.den.berg@isala.nl
Contact: L. N. Boom	+31 38 4242000 ext 4543	l.n.boom@isala.nl

Locations

Netherlands
Isala Klinieken	Recruiting
Zwolle, Netherlands, 8011 JW
Principal Investigator: Lisenka Boom, MD

Sponsors and Collaborators

Isala Klinieken

Investigators

Study Director:

Jan Willem Van Den Berg, MD

Departement of Pulmonology

More Information

No publications provided

Responsible Party:	Isala Klinieken ( L.N. Boom )
Study ID Numbers:	NL14828.075.06
Study First Received:	March 28, 2007
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00453765 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Isala Klinieken:

cough
hyperreactivity
montelukast

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Hormone Antagonists
Respiration Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Cough

Pharmacologic Actions
Leukotriene Antagonists
Montelukast
Signs and Symptoms
Respiratory Tract Diseases
Therapeutic Uses
Signs and Symptoms, Respiratory
Bronchial Hyperreactivity

ClinicalTrials.gov processed this record on February 08, 2010