The Effect of Prednisone on Physical Exercise in COPD Pat... | NCT01978665

Studies
The Effect of Prednisone on Physical Exercise in COPD Patients

NCT01978665

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Feb 5, 2020Actual

Enrollment

14Actual

Phase

Phase 4

Conditions

Exercise Performance in Copd Patients

Interventions

prednisone

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-004503-13	EudraCT Number

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013Actual

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Nov 1, 2013

First Submission Date that Met QC Criteria

Nov 6, 2013

First Posted Date

Nov 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2020

Last Update Posted Date

Feb 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
prednisone	Drug	similar size tablets	placebo prednisone and Solumedrol solumedrol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vibeke Backer, professor	Bispebjerg Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital		Copenhagen	NV	2400	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D011241	Prednisone

Ancestor Terms

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

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