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
Bronchial Hyperreactivity
Drug: montelukast
Drug: placebo
Phase 4

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:

Further study details as provided by Isala:

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 ]

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
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Isala:

Additional relevant MeSH terms:
Bronchial Hyperreactivity
Bronchial Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Anti-Asthmatic Agents
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 22, 2016