Overview

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

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Isala
Treatments:
Montelukast
Criteria
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.