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
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Prospective Single-centre, Double Blind Randomised Trial of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2010 (Final data collection date for primary outcome measure)
montelukast, 8 weeks, once daily, 10 milligrams
Other Name: singulair
Placebo Comparator: B
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- abnormal chest X-ray.
- use of medication inducing CYP3A4 (for example; fenytoïne, phenobarbital or rifampicin.
- use of medication metabolised by CYP2C8.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453765
|Zwolle, Netherlands, 8011 JW |
||Jan Willem Van Den Berg, MD
||Departement of Pulmonology
No publications provided
||Jan W.K. van den Berg, Dr., Isala Klinieken
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 28, 2007
||April 5, 2013
||Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Keywords provided by Isala Klinieken:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 19, 2013
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Respiratory System Agents