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

ISRCTN	ISRCTN23612807
DOI	https://doi.org/10.1186/ISRCTN23612807
Secondary identifying numbers	MOP-36329

Submission date: 19/10/2006
Registration date: 21/12/2007
Last edited: 21/12/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Yves Lacasse
Scientific

Centre de Pneumologie
Hôpital Laval
2725 chemin Ste-Foy
Québec
G1V 4G5
Canada

Phone	+1 418 656 4747
Email	yves.lacasse@med.ulaval.ca

Study information

Study design	A 3-year, multicentre, placebo-controlled, randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	CANOX trial
Study objectives	Long-term oxygen therapy (LTOT) is the only component of the management of chronic obstructive pulmonary disease (COPD) that improves survival in patients with severe daytime hypoxemia. In Canada, LTOT is usually provided by a stationary oxygen concentrator and is recommended to be used for at least 15 - 18 hours a day. Several studies have demonstrated a deterioration in arterial blood gas pressures and oxygen saturation during sleep in patients with COPD. Sleep-related oxygen desaturation often occurs in patients not qualifying for LTOT. The suggestion has been made that the natural progression of COPD to its end stages of chronic pulmonary hypertension, severe hypoxemia, right heart failure, and death is dependent upon the severity of desaturation occurring during sleep. This is an attractive hypothesis and is supported by the fact that hypoxemic episodes during sleep are accompanied by substantial increases in pulmonary arterial pressure and often by important cardiac arrhythmias. Supplemental nocturnal oxygen alleviates both the acute increases in pulmonary arterial pressure and the cardiac arrhythmias. It has been suggested that, over the long run, nocturnal oxygen therapy (N-O2) may halt the progression of long-standing cor pulmonale and prolong survival. Probably due to the fact that the recommendations of scientific societies regarding the indications for and use of N-O2 in COPD not qualifying for conventional LTOT are presently imprecise, a number of patients are currently treated with N-O2 although the beneficial effects of this therapy have not been confirmed. Hypothesis: In patients with Chronic Obstructive Pulmonary Disease (COPD) not qualifying for Long Term Oxygen Therapy (LTOT) but who present significant nocturnal arterial oxygen desaturation, nocturnal oxygen therapy provided for a period of 3 years is effective in decreasing mortality or delaying the requirement for LTOT, and is cost-effective and favourably compares to other medical interventions
Ethics approval(s)	Pending as of 20/10/2006.
Health condition(s) or problem(s) studied	Chronic obstructive pulmonary disease (COPD)
Intervention	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 delivered by sham concentrator
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Nocturnal oxygen therapy
Primary outcome measure	The primary outcomes of this trial are mortality from all cause or requirement for LTOT (composite outcome).
Secondary outcome measures	1. Quality of life and utility measures 2. Costs from a societal perspective 3. Compliance with oxygen therapy
Overall study start date	01/09/2008
Completion date	01/09/2013

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	600
Key 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
Key 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)
Date of first enrolment	01/09/2008
Date of final enrolment	01/09/2013

Locations

Countries of recruitment

Canada

Study participating centre

Centre de Pneumologie

Québec
G1V 4G5
Canada

Sponsor information

Laval University (Canada)
University/education

Cité Universitaire
C.P. 2208
Québec
G1K 7P4
Canada

Email	yves.lacasse@med.ulaval.ca
Website	http://www.ulaval.ca/
"ROR"	https://ror.org/04sjchr03

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-36329)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan