The International Nocturnal Oxygen (INOX) Trial (INOX)

Study Description

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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 Design

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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
Estimated Primary Completion Date :	January 2019
Estimated Study Completion Date :	January 2019

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. Composite outcome: all-cause mortality or requirement for continuous oxygen therapy [ Time Frame: Every 2 months ]
   All-cause mortality or requirement for continuous oxygen therapy

Secondary Outcome Measures :

1. Quality of life [ Time Frame: Once a year ]
   St-George's respiratory questionnaire and SF-36 questionnaire
2. Health economics [ Time Frame: Every 2 months ]
   Costs and health care utilization

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
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.

Contacts and Locations

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Locations

Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G8
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
St-Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Hôpital Dr Georges-L. Dumont
Moncton, New Brunswick, Canada, E1C 2Z3
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
The Ottawa Hospital (General Campus)
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Centre de la santé et des services sociaux de Laval (Cité de la Santé de Laval)
Laval, Quebec, Canada, H7V 3Y7
Hôtel-Dieu de Lévis
Lévis, Quebec, Canada, G6V 3Z1
Montreal Chest Institute
Montreal, Quebec, Canada, H3X 2P4
Centre Hospitalier Mount-Sinai
Montreal, Quebec, Canada, H4W 1S7
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada, G1V 4G5
Hôpital régional de Saint-Jérôme
Saint-Jérôme, Quebec, Canada, J7Z 5T3
CHUS, Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Centre de recherche Pneumomédic inc.
Trois-Rivières, Quebec, Canada, G8T 7A4
France
Hôpital Nord de Marseille
Marseille, France, 13015
Groupe Hospitalier Pitié - Salpêtrière
Paris, France, 75651 Paris cedex 13
CHU de Poitiers
Poitiers, France, 86000
Portugal
Centro Hospitalar do Barlavento Algarvio - EPE
Portimao, Algarve, Portugal
Centro Hospitalar de Coimbra
Coimbra, Portugal
Centro Hospitalar da Cova da Beira
Covilha, Portugal
Hospital Pulido Valente - Centro Hospitalar Lisboa Norte
Lisboa, Portugal
Hospital Pedro Hispano Unidade Local de Saude de Matosinhos
Matosinhos, Portugal
Centro Hospitalara Vila Nova de Gaia-Espinho EPE
Vila Nova de Gaia, Portugal
Spain
Hospital Galdakao-Usansolo
Galdakao, Biskaia, Spain, 48960
Hospital Universitario de Getafe
Getafe, Spain, 28905
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Txagorritxu
Vitoria-Gasteiz, Spain, 01008

Sponsors and Collaborators

Laval University

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:	Yves Lacasse, MD, MSc	Laval University

More Information

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Publications:

Lacasse Y, Sériès F, Martin S, Maltais F. Nocturnal oxygen therapy in patients with chronic obstructive pulmonary disease: a survey of Canadian respirologists. Can Respir J. 2007 Sep;14(6):343-8.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lacasse Y, Bernard S, Sériès F, Nguyen VH, Bourbeau J, Aaron S, Maltais F; International Nocturnal Oxygen (INOX) Research Group. Multi-center, randomized, placebo-controlled trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease: a study protocol for the INOX trial. BMC Pulm Med. 2017 Jan 9;17(1):8. doi: 10.1186/s12890-016-0343-9.

Responsible Party:	Yves Lacasse, Professeur, Laval University
ClinicalTrials.gov Identifier:	NCT01044628 History of Changes
Other Study ID Numbers:	MCT-99512
First Posted:	January 8, 2010
Last Update Posted:	March 8, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Yves Lacasse, Laval University:

COPD; Oxygen therapy; Nocturnal; Desaturation; INOX

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases