The International Nocturnal Oxygen (INOX) Trial (INOX)
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|ClinicalTrials.gov Identifier: NCT01044628|
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease Nocturnal Desaturation||Device: Concentrator Device: Sham concentrator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||243 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Multi-Center Randomized Placebo-controlled Trial of Nocturnal Oxygen Therapy in Chronic Obstructive Pulmonary Disease. The International Nocturnal Oxygen (INOX) Trial|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||January 2019|
Experimental: Nocturnal oxygen therapy (N-O2)
Oxygen will be delivered overnight to the patients to allow their oxygen saturation to be >90%
Patients allocated to the study group will receive oxygen overnight from an electrically-powered oxygen concentrator (NewLife Intensity Oxygen Concentrator, AirSep Corporation, Buffalo, NY, USA), to allow the oxygen saturation to be >90%
Sham Comparator: Sham concentrator
Sham therapy with ambient air will be given to the patients at night
Device: Sham concentrator
Patients allocated to the control group will receive ambient air delivered overnight through an electrically-powered oxygen concentrator (NewLife Intensity Oxygen Concentrator, Airsep Corporation, Buffalo, NY, USA) rendered ineffective by bypassing the sieve beds. The ineffective concentrators will have the same external appearance as the effective ones, allowing the trial to be double-blinded. We have requested approval by Health Canada in order to proceed with the modifications on the oxygen concentrators. Written permission is pending.
- Composite outcome: all-cause mortality or requirement for continuous oxygen therapy [ Time Frame: From date of randomization until the date of prescription of continuous oxygen or date of death from any cause, whichever came first, assessed up to 48 months ]Proportion of patients who died (from any cause) OR required continuous oxygen therapy
- Disease-specific quality of life [ Time Frame: 48 months ]St-George's respiratory questionnaire; 3 domains analyzed separately : (1) symptoms; (2) activity; (3) impact. Score range for each domain: 0 - 100%; summary score: 0% (perfect health) to 100% (worst).
- Generic quality of life [ Time Frame: 48 months ]Medical Outcome Survey - Short Form 36 (SF-36); 8 domains analyzed separately: (1) Physical functioning; (2) Role - physical; (3) Bodily pain; (4) General health perception; (5) Energy/vitality ; (6) Social functioning; (7) Role - emotions; (8) Mental health. Domain score and overall score: 0 to 100. Higher score = better health.
- Health economics [ Time Frame: 48 months ]Costs and health care utilization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044628
|Principal Investigator:||Yves Lacasse, MD, MSc||Laval University|