We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00453765
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : April 8, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Cough Bronchial Hyperreactivity Drug: montelukast Drug: placebo Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2007
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
Drug Information available for: Montelukast
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
montelukast
Drug: montelukast
montelukast, 8 weeks, once daily, 10 milligrams
Other Name: singulair
Placebo Comparator: B
placebo
Drug: placebo
placebo


Outcome Measures

Primary Outcome Measures :
  1. Difference in average score on the Leicester Cough Questionnaire (LCQ) between the two treatment groups; montelukast vs placebo. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Difference in cough VAS scores; montelukast vs placebo. [ Time Frame: 2 years ]
  2. Comparison of the adverse events of montelukast vs placebo. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453765


Locations
Netherlands
Isala Klinieken
Zwolle, Netherlands, 8011 JW
Sponsors and Collaborators
Isala
Investigators
Study Director: Jan Willem Van Den Berg, MD Departement of Pulmonology
More Information

Responsible Party: Jan W.K. van den Berg, Dr., Isala Klinieken
ClinicalTrials.gov Identifier: NCT00453765     History of Changes
Other Study ID Numbers: NL14828.075.06
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by Jan W.K. van den Berg, 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
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action