Chronic cough ( cough lasting > 8 weeks).
Conditions
Interventions
Pharmaceutical Form:
Sponsors
there is no sponsor.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Montelukast study: 1. patients between 16 and 90 years old, referred to the cough outpatient clinic with chronic cough and enhanced bronchial hyperreactivity. 2. chronic cough is defined as a cough > 8 weeks duration. 3. enhanced bronchial hyperreactivity is a PD20 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: both studies: 1. concomitant severe disease. 2. patients suffering from COPD and / or other relevant lung diseases. 3. clinically relevant abnormal laboratory values suggesting an unknown disease requiring further clinical evaluation. 4. 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. 5. pregnancy. 6. abnormal chest X-ray. 7. intolerance to either montelukast or to amitriptyline in either study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This protocol contains two studies in patients with chronic cough, ie. the montelukast study and the amitriptyline study. -The purpose of the montelukast study is to determine if montelukast has superior antitussive effects compared with placebo in patients with cough lasting > 8 weeks and enhanced bronchial hyperreactivity. -The purpose of the amitriptyline study is to investigate if the administration of amitriptyline has antitussive effects in patients with chronic intractable cough.;Secondary Objective: Are there adverse effects of montelukast and amitriptylline?;Primary end point(s): Main study endpoint montelukast study: 1. difference in average score on the Leicester Cough Questionaire (LCQ) between the two treatment groups; montelukast vs placebo. Main Study endpoint amitriptyline study: 1. difference in LCQ scores form day 0-6 weeks. | — |
Countries
Netherlands
Outcome results
None listed