NCT01978665

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 5, 2020

Status Verified

November 1, 2013

Enrollment Period

8 months

First QC Date

November 1, 2013

Last Update Submit

January 31, 2020

Conditions

Exercise Performance in Copd Patients

Keywords

COPD exercise inflammation prednisone

Outcome Measures

Primary Outcomes (1)

  • effect on muscle power

    muscular strenght

    jan 2013 to july 2013 (6 months)

Secondary Outcomes (1)

  • the inflammatory response

    jan 2013 to july 2013 (6 months)

Other Outcomes (2)

  • vo2max

    jan 2013 to july 2013 ( 6 months)

  • VO2max

    jan 2013 until july 2013 (6 months)

Study Arms (3)

prednisone and Solumedrol

PLACEBO COMPARATOR

placebo arm versus prednisone

Drug: prednisone

solumedrol

PLACEBO COMPARATOR

placebo versus solu medrol

Drug: prednisone

placebo

OTHER

measurement of fitness

Drug: prednisone

Interventions

prednisoneDRUG

similar size tablets

Also known as: placebo
placeboprednisone and Solumedrolsolumedrol

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • able to use a ergometer bike

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, NV, 2400, Denmark

Location

MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Vibeke Backer, professor

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: RCT study with steroid.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 7, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 5, 2020

Record last verified: 2013-11

Locations

DK(1)