E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To investigate the effects of prednisone and Solu-Medrol on physical performance in patients with chronic obstructive pulmonary disease(COPD). Furthermore to examine the inflammatory response during and after exercise in patients with COPD |
To investigate the effects of prednisone and Solu-Medrol on physical performance in patients with chronic obstructive pulmonary disease(COPD). Furthermore to examine the inflammatory response during and after exercise in patients with COPD |
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E.1.1.1 | Medical condition in easily understood language |
COPD is an obstructive respiratory disease with destruction and remodelling of the lung tissue, resulting in decreased lung function, shortness og breath and coughing. |
COPD is an obstructive respiratory disease with destruction and remodelling of the lung tissue, resulting in decreased lung function, shortness og breath and coughing. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 this trial is to investigate the effects of the drugs prednisone and Solu-Medrol on physical performance in patients with COPD |
The purpose of this trial is to investigate the effects of the drugs prednisone and Solu-Medrol on physical performance in patients with COPD |
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E.2.2 | Secondary objectives of the trial |
To examine the inflammatory response during and after exercise in patients with COPD |
To examine the inflammatory response during and after exercise in patients with COPD |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
sex: male
age 40-75
FEV1<60%
In a physical conditíon that allows cycling
smoker or ex smoker
informed consent
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E.4 | Principal exclusion criteria |
haemodynamicaly unstable heart conditions ie heart failure, atrial fibrilation and angina pectoris
other respiratory diseases
cancer the last 5 years
treatment with beta blockers
allergi to study medication
insuline treated diabetes
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E.5 End points |
E.5.1 | Primary end point(s) |
prednisone and solumedrol improves cycling performance |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1,5 years from first participant |
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E.5.2 | Secondary end point(s) |
prednisonae and Solu-Medrol improves muscle power. to examine the inflammatory response during exercise during treatment with glucocorticoids |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 |
ergogenic effects of prednisone and solumedrol |
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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 | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
the trial is in 2 parts 1 is a cross over 2 is parallel |
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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 has ended the last study visit in the clinic |
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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 | |
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 |