The Canadian Nocturnal Oxygen (CANOX) trial

ISRCTN	ISRCTN50085100
DOI	https://doi.org/10.1186/ISRCTN50085100
ClinicalTrials.gov (NCT)	NCT01044628
Protocol serial number	MCT-99512
Sponsor	Laval Hospital (Hôpital Laval) (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) (ref: MCT-99512)

Submission date: 16/09/2009
Registration date: 21/09/2009
Last edited: 23/04/2021

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

06/06/2019: This record contains out of date information and will not be updated further. Please see https://clinicaltrials.gov/ct2/show/NCT01044628 for the most up to date trial record.

Plain English summary not provided at time of registration.

Contact information

Dr Yves Lacasse
Scientific

Centre de recherche de lInstitut de cardiologie et de pneumologie de Québec (CRICPQ)
Hôpital Laval
2725 Chemin Ste-Foy
Québec
G1V 4G5
Canada

Email	yves.lacasse@med.ulaval.ca

Study information

Primary study design	Interventional
Study design	Multicentre placebo-controlled randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Multicentre randomised placebo-controlled trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease
Study acronym	CANOX, INOX
Study objectives	In patients with chronic obstructive pulmonary disease (COPD) not qualifying for long-term oxygenotherapy (LTOT) but who present significant nocturnal arterial oxygen desaturation, nocturnal oxygen (N-O2) provided for a period of 3 years is effective in decreasing mortality or delaying the requirement for LTOT, and is cost-effective and favorably compares to other medical interventions.
Ethics approval(s)	Local medical ethics committee (Comité d'éthique de la recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec [Hôpital Laval]) pending approval; meeting planned for 03/11/2009
Health condition(s) or problem(s) studied	Chronic obstructive pulmonary disease (COPD)
Intervention	Nocturnal oxygen therapy (N-O2 study group): oxygen delivered overnight to allow the oxygen saturation to be greater than 90% Placebo (control group): room air delivered by defective concentrator The comparison will be double blind. COPD patients will be randomly assigned to 3 years of treatment with either home N-O2 or sham therapy with ambient air. Each patient will be followed-up for this period of 3 years, with regular visits (every 4 months) until one of the following events: the patient is prescribed LTOT or the patient dies.
Intervention type	Other
Primary outcome measure(s)	1. Mortality from all cause 2. Requirement for LTOT (composite outcome) The usual socio-demographic and clinical characteristics will be obtained at baseline. Spirometry will be performed according to the American Thoracic Society requirements, lung volumes measurement by plethysmography, and carbon monoxide diffusion capacity measurement by the single-breath method (all measured at baseline, 12, 24 and 36 months). All arterial blood gases will be measured while breathing at room air (measured at baseline and every 4 months until 36 months). In case of death, the date at which the primary outcome is reached will be obtained directly from chart review, contact with the treating physician or on the basis of interviews with surviving relatives during the protocol-based home visits or telephone interviews.
Key secondary outcome measure(s)	1. Quality of life and utility measures, measured at baseline, 12 months, 24 months and 36 months 2. Costs from a societal perspective, measured through telephone contacts with patients every two months 3. Compliance with oxygen therapy, measured at 4, 8, 12, 16, 20, 24, 28, 32 and 36 months
Completion date	01/03/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	630
Total final enrolment	243
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/03/2010
Date of final enrolment	01/03/2014

Locations

Countries of recruitment

Canada

Study participating centre

Centre de recherche de lInstitut de cardiologie et de pneumologie de Québec (CRICPQ)

Québec
G1V 4G5
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		17/09/2020	23/04/2021	Yes	No
Protocol article	protocol	09/01/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. "INOC" has been added to the acronyms.
06/06/2019: This record contains out of date information and will not be significantly updated. Please see https://clinicaltrials.gov/ct2/show/NCT01044628 for the most up to date trial record.
25/04/2019: Internal review.
11/01/2017: Publication reference added.