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. Identifier: NCT00453765
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : April 8, 2013
Information provided by (Responsible Party):
Jan W.K. van den Berg, Isala

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 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
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
Drug Information available for: Montelukast

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

Placebo Comparator: B
Drug: placebo

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00453765

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

Responsible Party: Jan W.K. van den Berg, Dr., Isala 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:

Additional relevant MeSH terms:
Bronchial Hyperreactivity
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
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