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Trial record 1 of 4 for:    inox
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The International Nocturnal Oxygen (INOX) Trial (INOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01044628
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Yves Lacasse, Laval University

Brief Summary:
This multicenter randomized placebo controlled trial aims to determine if in patients with COPD not qualifying for LTOT but presenting significant nocturnal arterial oxygen desaturation, whether nocturnal oxygen therapy provided for a period of 4 years decreases mortality or delay the prescription of LTOT.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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%
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
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. Health economics [ Time Frame: 48 months ]
    Costs and health care utilization



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Laval University
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Yves Lacasse, MD, MSc Laval University
  Study Documents (Full-Text)

Documents provided by Yves Lacasse, Laval University:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Keywords provided by Yves Lacasse, Laval University:
COPD
Oxygen therapy
Nocturnal
Desaturation
INOX
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases