Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592033
• Other study ID #: 2007-41-0569
• Status: Completed
• Phase: Phase 4
• First received: December 31, 2007
• Last updated: March 21, 2012
• Start date: May 2007
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• oxygen from a portable concentrator
2 l/minute during exercise

Locations

Country	Name	City	State
Denmark	University Hospital, Hvidovre, Cardio-pulmonary depart.	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Danish Lung Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shuttle walk (endurance time)		7 week, 3 and 6 months	No
Secondary	St. George Respiratory Questionnaire		7 week, 3 and 6 months	No
Secondary	Usage of oxygen concentrator (Spent time according to the meter)		7 weeks, 3 and 6 months	No
Secondary	Exacerbations requiring medical treatment (prednisolone or antibiotics)		7 weeks, 3 and 6 months	No
Secondary	Hospitalisation		7 weeks, 3 and 6 months	No
Secondary	Mortality		7 weeks, 3 and 6 months	No