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Examining the effect of the anti inflammatory medicine prednisolone on physical performance in patients with COPD and changes in immune response after exercise

Conditions
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
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Registration Number
EUCTR2012-004503-13-DK
Lead Sponsor
Bispebjerg Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
Male
Target Recruitment
14
Inclusion Criteria

sex: male
age 40-75
FEV1<60%
In a physical conditíon that allows cycling
smoker or ex smoker
informed consent

Are the trial subjects under 18? no
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 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: The purpose of this trial is to investigate the effects of the drugs prednisone and Solu-Medrol on physical performance in patients with COPD;Secondary Objective: To examine the inflammatory response during and after exercise in patients with COPD;Primary end point(s): prednisone and solumedrol improves cycling performance;Timepoint(s) of evaluation of this end point: 1,5 years from first participant
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s): prednisonae and Solu-Medrol improves muscle power. to examine the inflammatory response during exercise during treatment with glucocorticoids;Timepoint(s) of evaluation of this end point: 1,5 years
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