The Canadian Nocturnal Oxygen (CANOX) trial

Not Applicable

Completed

• Conditions: Chronic obstructive pulmonary disease (COPD); Respiratory; Other chronic obstructive pulmonary disease

• Registration Number: ISRCTN50085100
• Lead Sponsor: aval Hospital (Hôpital Laval) (Canada)

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28069009 2020 results in https://pubmed.ncbi.nlm.nih.gov/32937046/ (added 23/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-21
• Study Completion: 2014-03-01
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 243

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Mortality from all cause<br> 2. Requirement for LTOT (composite outcome)<br><br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Quality of life and utility measures, measured at baseline, 12 months, 24 months and 36 months<br> 2. Costs from a societal perspective, measured through telephone contacts with patients every two months<br> 3. Compliance with oxygen therapy, measured at 4, 8, 12, 16, 20, 24, 28, 32 and 36 months<br>