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

This study has been completed.
Information provided by (Responsible Party):
Jan W.K. van den Berg, Isala Klinieken Identifier:
First received: March 28, 2007
Last updated: April 5, 2013
Last verified: April 2013
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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Jan W.K. van den Berg, 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 ]

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

Enrollment: 89
Study Start Date: December 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Drug: montelukast
montelukast, 8 weeks, once daily, 10 milligrams
Other Name: singulair
Placebo Comparator: B
Drug: placebo

  Show Detailed Description


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00453765

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

Responsible Party: Jan W.K. van den Berg, Dr., Isala Klinieken Identifier: NCT00453765     History of Changes
Other Study ID Numbers: NL14828.075.06
Study First Received: March 28, 2007
Last Updated: April 5, 2013

Keywords provided by Jan W.K. van den Berg, Isala Klinieken:

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 processed this record on August 18, 2017