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.