Multicentre randomised placebo-controlled trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease

Completed

• Conditions: Chronic obstructive pulmonary disease (COPD); Respiratory

• Registration Number: ISRCTN23612807
• Lead Sponsor: aval University (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

1. Patients with a diagnosis of COPD supported by an history of past or current smoking and obstructive disease with forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) less than 60%
2. Presence of mild-to-moderate daytime hypoxemia with a daytime partial pressure of oxygen in arterial blood (paO2) in the range of 56 - 69 mmHg
3. Patients fulfilling our definition of nocturnal oxygen desaturation: greater than or equal to 30% of the recording time with transcutaneous arterial oxygen saturation less than 90% on two consecutive recordings

Exclusion Criteria

1. Patients fulfilling the usual criteria for continuous oxygen therapy (CONT-O2) at study entry:
1.1. PaO2 less than or equal to 55 mmHg, or
1.2. PaO2 less than or equal to 59 mmHg with clinical evidence of at least one of the following:
1.2.1. Pulmonary hypertension
1.2.2. Right ventricular hypertrophy
1.2.3. Cor pulmonale
1.2.4. Haematocrit greater than or equal to 55%
2. Patients with sleep apnea (defined by an apnoea/hypopnoea index of greater than or equal to 15 events/hour
3. Patients currently on nocturnal oxygen therapy (N-O2)
4. Patients with known left heart or congenital heart diseases, interstitial lung diseases, bronchiectasis as the main cause of their obstructive disease, lung carcinoma or other severe diseases that could influence survival (hepatic cirrhosis and chronic renal failure)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcomes of this trial are mortality from all cause or requirement for LTOT (composite outcome).

Secondary Outcome Measures

Name	Time	Method
1. Quality of life and utility measures<br>2. Costs from a societal perspective <br>3. Compliance with oxygen therapy