The Effect of Prednisone on Physical Exercise in COPD Patients (COPDpred)

January 31, 2020 updated by: Vibeke Backer, Bispebjerg Hospital

The Effect of Prednisone and Solu-Medrol on Physical Exercise in COPD Patients and the Inflammaroty Response During and After Exercis.

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

RCT study with 4 days of steroid

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • NV
      • Copenhagen, NV, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: prednisone and Solumedrol
placebo arm versus prednisone
Drug: prednisone
similar size tablets
Other Names:
  • placebo
Placebo Comparator: solumedrol
placebo versus solu medrol
Drug: prednisone
similar size tablets
Other Names:
  • placebo
Other: placebo
measurement of fitness
Drug: prednisone
similar size tablets
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect on muscle power
Time Frame: jan 2013 to july 2013 (6 months)
muscular strenght
jan 2013 to july 2013 (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the inflammatory response
Time Frame: jan 2013 to july 2013 (6 months)
hsCRP
jan 2013 to july 2013 (6 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
vo2max
Time Frame: jan 2013 to july 2013 ( 6 months)
fitness
jan 2013 to july 2013 ( 6 months)
VO2max
Time Frame: jan 2013 until july 2013 (6 months)
fitness
jan 2013 until july 2013 (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 1, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-004503-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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