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)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by Isala Klinieken. Recruitment status was Recruiting

First Received on March 28, 2007. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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
Experimental: A montelukast	Drug: montelukast montelukast, 8 weeks, once daily, 10 milligrams Other Name: singulair
Placebo Comparator: B 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:	L.N. Boom, Isala Klinieken
ClinicalTrials.gov Identifier:	NCT00453765 History of Changes
Other Study ID Numbers:	NL14828.075.06
Study First Received:	March 28, 2007
Last Updated:	March 25, 2009
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Isala Klinieken:

cough
hyperreactivity
montelukast

Additional relevant MeSH terms:

Cough
Bronchial Hyperreactivity
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Montelukast

Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012