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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23612807

Enrollment

600

Registered

2007-12-21

Start date

2008-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory Chronic obstructive pulmonary disease (COPD)

Interventions

1. Nocturnal oxygen therapy group: N-O2 will be delivered overnight to allow the oxygen saturation to be greater than 90% 2. Placebo: the patients allocated in the control group will receive room air

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. Quality of life and utility measures 2. Costs from a societal perspective 3. Compliance with oxygen therapy	—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026