E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To investigate the effects of terbutaline on repeated exercise performance in patients with chronic obstructive pulmonary disease (COPD). Furthermore to examine the inflammatory response during and after exercise in patients with COPD. |
|
E.1.1.1 | Medical condition in easily understood language |
COPD is a obstructive respiratory disease with destruction and remodelling of the lung tissue, resulting in decreased lung function, shortness of breath and coughing. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
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 |
The purpose of the study is to investigate the effects of high dose terbutaline on repeated exercise performance in patients with COPD |
|
E.2.2 | Secondary objectives of the trial |
To examine the inflammatory respons during and after exercise in patients with COPD |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Sex: Male
-Age: 45-75
-COPD classified as GOLD2, with a FEV1 between 30 and 50%
-In a physical condition that allows cycling
-smoker or former smoker
-Informed consent |
|
E.4 | Principal exclusion criteria |
-Cardiovascular diseases
-Other respiratory diseases than COPD, as well as, lung cancer
-Allergy towards the study medicine
-Use of beta2-agonist 48 hours prior to study days
-COPD rehabilitation 3 months prior to study
-Patients treated with beta-blockers |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Terbutaline improves repeated cycling performance |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
appr. 1.5 year from first participant |
|
E.5.2 | Secondary end point(s) |
Terbutaline improves skeletal muscle power. Terbutaline increases inflammatory due to larger metabolic stress in working skeletal muscles |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
appr. 1.5 year from first participant |
|
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 | No |
E.6.4 | Safety | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Effects of terbutaline on repeated exercise performance |
|
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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
The clinical trial ends when the last subject (subject no. 10) has ended his last study visist at the clinic |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |