NCT01978665CompletedPhase 4
The Effect of Prednisone and Solu-Medrol on Physical Exercise in COPD Patients and the Inflammaroty Response During and After Exercis.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- effect on muscle power
Study Overview
Brief Summary
The objective of this study is to investigate if there is an effect on exercise performance og of the anti inflammatory drugs prednisone and solu-medrol in patints with chronic obstructive pulmonary disease(COPD)
Detailed Description
RCT study with 4 days of steroid
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •FEV1< 60% FEV1/FVC ratio <70 %
- •able to use a ergometer bike
Exclusion Criteria
- •Haemodynamicaly unstable heart conditions
- •exacerbations before 6 week entry of the study exacerbation during the study period treatment with beta blockers malignancy the last 5 years allergi toward IMP
Arms & Interventions
prednisone and Solumedrol
Placebo Comparator
placebo arm versus prednisone
Intervention: prednisone (Drug)
solumedrol
Placebo Comparator
placebo versus solu medrol
Intervention: prednisone (Drug)
placebo
Other
measurement of fitness
Intervention: prednisone (Drug)
Outcomes
Primary Outcomes
effect on muscle power
Time Frame: jan 2013 to july 2013 (6 months)
muscular strenght
Secondary Outcomes
- the inflammatory response(jan 2013 to july 2013 (6 months))
Investigators
Vibeke Backer
professor
Bispebjerg Hospital
Study Sites (1)
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