Contact information
Type
Scientific
Primary contact
Dr Yves Lacasse
ORCID ID
Contact details
Centre de Pneumologie
Hôpital Laval
2725 chemin Ste-Foy
Québec
G1V 4G5
Canada
+1 418 656 4747
yves.lacasse@med.ulaval.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MOP-36329
Study information
Scientific title
Acronym
CANOX trial
Study hypothesis
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
Pending as of 20/10/2006.
Study design
A 3-year, multicentre, placebo-controlled, randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Nocturnal oxygen therapy
Primary outcome measures
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 trial start date
01/09/2008
Overall trial end date
01/09/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
600
Participant 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)
Recruitment start date
01/09/2008
Recruitment end date
01/09/2013
Locations
Countries of recruitment
Canada
Trial participating centre
Centre de Pneumologie
Québec
G1V 4G5
Canada
Sponsor information
Organisation
Laval University (Canada)
Sponsor details
Cité Universitaire
C.P. 2208
Québec
G1K 7P4
Canada
yves.lacasse@med.ulaval.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-36329)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary