Effect of Oxygen in Normoxaemic COPD Patients Who Desatur... | NCT00592033

Studies
Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise

NCT00592033

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Mar 22, 2012Estimated

Enrollment

45Actual

Phase

Phase 4

Conditions

COPD

Interventions

oxygen from a portable concentrator

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

Status Module

Record Verification Date

Mar 2012

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

May 2007

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Dec 31, 2007

First Submission Date that Met QC Criteria

Dec 31, 2007

First Posted Date

Jan 11, 2008Estimated

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

Mar 21, 2012

Last Update Posted Date

Mar 22, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas Ringbaek, Senior Consultant, Hvidovre University HospitalPrincipal Investigator

Lead Sponsor

Hvidovre University HospitalOTHER

Collaborators

Name	Class
Danish Lung Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

In COPD patients with desaturation during exercise, several studies have shown an acute beneficial effect of supplemental oxygen. Therefore, both the British Thoracic Society and the American Thoracic Society guidelines recommend supplemental oxygen to patients who desaturate >4% and to below 88-90%. However, long-term studies have not been able to support this intervention. In this study of COPD patients, who desaturate and participate in a 7-week pulmonary rehabilitation programme, we examine the effect of supplemental oxygen on exercise tolerance, health status, and exacerbation rates. In a randomised design patients trained either with room air or with 2 litres oxygen per minute from a portable oxygen concentrator. All patients were asked to exercise every day for 30 minutes.

Detailed Description

In COPD patients with desaturation during exercise, several studies have shown an acute beneficial effect of supplemental oxygen. Therefore, both the British Thoracic Society and the American Thoracic Society guidelines recommend supplemental oxygen to patients who desaturate >4% and to below 88-90%. However, long-term studies have not been able to support this intervention. In this study of COPD patients, who desaturate and participate in a 7-week pulmonary rehabilitation programme, we examine the effect of supplemental oxygen. Using a randomised design, patients trained either with room air (control) or with 2 litres oxygen per minute from a portable oxygen concentrator. All patients were asked to exercise every day for 30 minutes.

Primary effect parameters:

endurance shuttle walk time at baseline, 7 weeks (after intensive supervised rehabilitation), 3 months (after maintenance training twice a month), and after 6 months.

Secondary effect parameters:

St. George Respiratory Questionnaire (health status); usage of oxygen, exacerbations requiring medical treatment, hospitalisation and mortality in the same periods.

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

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	No Intervention	Rehabilitation, no supplemental oxygen
1	Experimental	Rehabilitation plus supplemental oxygen	Other: oxygen from a portable concentrator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxygen from a portable concentrator	Other	2 l/minute during exercise	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Shuttle walk (endurance time)		7 week, 3 and 6 months

Secondary Outcomes

Measure	Description	Time Frame
St. George Respiratory Questionnaire		7 week, 3 and 6 months
Usage of oxygen concentrator (Spent time according to the meter)		7 weeks, 3 and 6 months
Exacerbations requiring medical treatment (prednisolone or antibiotics)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COPD
participate in a 7-weeks pulmonary rehabilitation programme
desaturate >4% to less than 90% during endurance shuttle walk test

Exclusion Criteria:

long-term oxygen therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas J Ringbaek, doctor	Hvidovre Hospital, University hospital, Cardio-pulmonary depart.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Hvidovre, Cardio-pulmonary depart.		Hvidovre		2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D009043	Motor Activity

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided