'Studies in patients with chronic cough; montelukast and amitriptyline studies’. - chronic cough studies.
- Conditions
- Chronic cough ( cough lasting > 8 weeks).
- Registration Number
- EUCTR2006-005533-38-NL
- Lead Sponsor
- there is no sponsor.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active
- Sex
- All
- Target Recruitment
- Not specified
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 < 2.5 mg metacholine.
1. amitriptyline study: patients between 16-90 years with no discernible
cause for coughing.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This protocol contains two studies in patients with chronic cough, ie. <br>the montelukast study and the amitriptyline study.<br>-The purpose of the montelukast study is to determine if montelukast has superior <br> antitussive effects compared with placebo in patients with cough lasting > 8 <br> weeks and enhanced bronchial hyperreactivity.<br>-The purpose of the amitriptyline study is to investigate if the administration of <br> 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:<br><br>1. difference in average score on the Leicester Cough Questionaire (LCQ) between <br> the two treatment groups; montelukast vs placebo.<br><br>Main Study endpoint amitriptyline study:<br><br>1. difference in LCQ scores form day 0-6 weeks.
- Secondary Outcome Measures
Name Time Method