E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic cough ( cough lasting > 8 weeks). |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
Are there adverse effects of montelukast and amitriptylline? |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
A cohort study with Amitriptyline for idiopathic cough. |
|
E.3 | Principal 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 < 2.5 mg metacholine.
1. amitriptyline study: patients between 16-90 years with no discernible cause for coughing. |
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |