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
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Condition or disease | Intervention/treatment | Phase |
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Chronic Obstructive Pulmonary Disease Nocturnal Desaturation | Device: Concentrator Device: Sham concentrator | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 243 participants |
Allocation: | Randomized |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Nocturnal oxygen therapy (N-O2)
Oxygen will be delivered overnight to the patients to allow their oxygen saturation to be >90%
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Device: Concentrator
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
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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

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with a diagnosis of COPD supported by a history of past smoking and obstructive disease: FEV1<70% predicted, FEV1/FVC<70% and a total lung capacity by body plethysmography >80% predicted;
- Stable COPD at study entry, as demonstrated by (1) no acute exacerbation and (2) no change in medications for at least 6 weeks before enrollment in the trial;
- Non-smoking patients for at least 6 months before enrollment in the trial;
- SpO2 at rest < 95%;
- Patients fulfilling the current definition of nocturnal oxygen desaturation, i.e., >=30% of the recording time with transcutaneous arterial oxygen saturation <90% on at least one of two consecutive recordings;
- Ability ot give informed consent.
Exclusion Criteria:
- Patients with severe hypoxemia fulfilling the usual criteria for continuous oxygen therapy at study entry: PaO2 <=55 mmHg; or PaO2 <= 59 mmHg with clinical evidence of at least one of the following: (1) with right ventricular hypertrophy (P pulmonale on ECG:3 mm leads ll, lll, aVf); (2) right ventricular hypertrophy; (3)Peripheral edema (cor pulmonale); (4) hematocrit >=55%;
- Patients with proven sleep apnea (defined by an apnea/hypopnea index of >=15 events/hour) or suspected sleep apnea on oximetry tracings;
- Patients currently using nocturnal oxygen therapy;
- 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 >= 40 kg/m²), or any other disease that could influence survival.

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 |
Documents provided by Yves Lacasse, Laval University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Yves Lacasse, Professeur, Laval University |
ClinicalTrials.gov Identifier: | NCT01044628 |
Other Study ID Numbers: |
MCT-99512 |
First Posted: | January 8, 2010 Key Record Dates |
Last Update Posted: | June 7, 2019 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
COPD Oxygen therapy Nocturnal Desaturation INOX |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |