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Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise

This study has been completed.
Sponsor:
Collaborator:
Danish Lung Association
Information provided by (Responsible Party):
Thomas Ringbaek, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00592033
First received: December 31, 2007
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
COPD
 Other: oxygen from a portable concentrator
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Ambulatory Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise. A Randomised Placebo Controlled Trial of Patients Who Participate in Pulmonary Rehabilitation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Shuttle walk (endurance time) [ Time Frame: 7 week, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • St. George Respiratory Questionnaire [ Time Frame: 7 week, 3 and 6 months ] [ Designated as safety issue: No ]
  • Usage of oxygen concentrator (Spent time according to the meter) [ Time Frame: 7 weeks, 3 and 6 months ] [ Designated as safety issue: No ]
  • Exacerbations requiring medical treatment (prednisolone or antibiotics) [ Time Frame: 7 weeks, 3 and 6 months ] [ Designated as safety issue: No ]
  • Hospitalisation [ Time Frame: 7 weeks, 3 and 6 months ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 7 weeks, 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: May 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 2
Rehabilitation, no supplemental oxygen
Experimental: 1
Rehabilitation plus supplemental oxygen
 Other: oxygen from a portable concentrator
2 l/minute during exercise

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592033

Locations
Denmark
University Hospital, Hvidovre, Cardio-pulmonary depart.
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Danish Lung Association
Investigators
Principal Investigator: Thomas J Ringbaek, doctor Hvidovre Hospital, University hospital, Cardio-pulmonary depart.
  More Information

No publications provided

Responsible Party: Thomas Ringbaek, Senior Consultant, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00592033     History of Changes
Other Study ID Numbers: 2007-41-0569
Study First Received: December 31, 2007
Last Updated: March 21, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
COPD oxygen
COPD rehabilitation
exercise

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013