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

aval Hospital (Hôpital Laval) (Canada)0 sites243 target enrollmentSeptember 21, 2009

Overview

Registry

who.int

Start Date

September 21, 2009

End Date

March 1, 2014

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

aval Hospital (Hôpital Laval) (Canada)

•1\. Patients with a diagnosis of COPD supported by a history of past or current smoking and obstructive disease: forced expiratory volume in one second (FEV1\) less than 50% predicted, FEV1/forced vital capacity (FVC) less than 70% and a total lung capacity by body plethysmography greater than 80% predicted
•2\. Stable COPD at study entry for at least 6 weeks before enrolment in the trial, as demonstrated by:
•2\.1\. No acute exacerbation
•2\.2\. No change in medications
•3\. Non\-smoking patients for at least 6 months before enrolment in the trial
•4\. Mild\-to\-moderate daytime hypoxaemia with a resting partial pressure of oxygen in arterial blood (PaO2\) (room air) in the range of 56 \- 69 mmHg
•5\. Patients fulfilling the current definition of nocturnal oxygen desaturation, i.e., greater than or equal to 30% of the recording time with transcutaneous arterial oxygen saturation less than 90% on at least one of two consecutive recordings
•6\. Ability to give informed consent
•7\. Men and women aged over 40 years of age

•1\. Patients with severe hypoxaemia fulfilling the usual criteria for continuous oxygen (CONT\-O2\) at study entry: PaO2 less than or equal to 55 mmHg or PaO2 less than or equal to 59 mmHg with clinical evidence of at least one of the following:
•1\.1\. Pulmonary hypertension
•1\.2\. Right ventricular hypertrophy
•1\.3\. Cor pulmonale
•1\.4\. Haematocrit greater than or equal to 55%
•2\. Patients with proven sleep apnoea (defined by an apnoea/hypopnoea index of greater than or equal to 15 events/hour) or suspected sleep apnoea on oximetry tracings
•3\. Patients currently using nocturnal oxygen therapy (NO2\)
•4\. Patients with known left heart or congenital heart diseases, interstitial lung diseases, bronchiectasis as the main cause of obstructive disease, lung carcinoma, severe obesity (body mass index greater than or equal to 40 kg/m^2\), or any other disease that could influence survival