Status:
COMPLETED
The Effect of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity
Lead Sponsor:
Isala
Conditions:
Cough
Bronchial Hyperreactivity
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 bro...
Detailed Description
Chronic cough is a frequent problem in general practice and one of the most common reasons for referral to a respiratory clinic. Prospective studies have shown that the vast majority of cases of chron...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00453765
Start Date
December 1 2007
End Date
September 1 2010
Last Update
April 8 2013
Active Locations (1)
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1
Isala Klinieken
Zwolle, Netherlands, 8011 JW