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
:
Active, not recruiting
First Posted
: January 8, 2010
Last Update Posted
: March 8, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
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
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 |
Principal Investigator: | Yves Lacasse, MD, MSc | Laval University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |