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COPDpred: The Effect of Prednisone on Physical Exercise in COPD Patients

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01978665
Collaborator
(none)
14
Enrollment
1
Location
3
Arms
8
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

RCT study with 4 days of steroid

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RCT study with steroid.RCT study with steroid.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Prednisone and Solu-Medrol on Physical Exercise in COPD Patients and the Inflammaroty Response During and After Exercis.
Actual Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. effect on muscle power [jan 2013 to july 2013 (6 months)]

      muscular strenght

    Secondary Outcome Measures

    1. the inflammatory response [jan 2013 to july 2013 (6 months)]

      hsCRP

    Other Outcome Measures

    1. vo2max [jan 2013 to july 2013 ( 6 months)]

      fitness

    2. VO2max [jan 2013 until july 2013 (6 months)]

      fitness

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bispebjerg Hospital Copenhagen NV Denmark 2400

    Sponsors and Collaborators

    • Bispebjerg Hospital

    Investigators

    • Principal Investigator: Vibeke Backer, professor, Bispebjerg Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vibeke Backer, professor, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT01978665
    Other Study ID Numbers:
    • 2012-004503-13
    • 2012-004503-13
    First Posted:
    Nov 7, 2013
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Nov 1, 2013
    Keywords provided by Vibeke Backer, professor, Bispebjerg Hospital
    COPD exercise inflammation prednisone
    Additional relevant MeSH terms:
    Prednisone

    Study Results

    No Results Posted as of Feb 5, 2020