Background: Long-term oxygen therapy (LTOT) is the only component of the management of chronic obstructive\npulmonary disease (COPD) that improves survival in patients with severe daytime hypoxemia. LTOT is usually provided\nby a stationary oxygen concentrator and is recommended to be used for at least 15ââ?¬â??18 h a day. Several studies have\ndemonstrated a deterioration in arterial blood gas pressures and oxygen saturation during sleep in patients with COPD,\neven in those not qualifying for LTOT. The suggestion has been made that the natural progression of COPD to its end\nstages of chronic pulmonary hypertension, severe hypoxemia, right heart failure, and death is dependent upon the\nseverity of desaturation occurring during sleep. The primary objective of the International Nocturnal Oxygen (INOX)\ntrial is to determine, in patients with COPD not qualifying for LTOT but who present significant nocturnal arterial\noxygen desaturation, whether nocturnal oxygen provided for a period of 3 years decreases mortality or delay the\nprescription of LTOT.\nMethods: The INOX trial is a 3-year, multi-center, placebo-controlled, randomized trial of nocturnal oxygen therapy\nadded to usual care. Eligible patients are those with a diagnosis of COPD supported by a history of past smoking and\nobstructive disease who fulfill our definition of significant nocturnal oxygen desaturation (i.e., ââ?°Â¥ 30% of the recording\ntime with transcutaneous arterial oxygen saturation < 90% on either of two consecutive recordings). Patients allocated\nin the control group receive room air delivered by a concentrator modified to deliver 21% oxygen. The comparison is\ndouble blind. The primary outcome is a composite of mortality from all cause or requirement for LTOT. Secondary\noutcomes include quality of life and utility measures, costs from a societal perspective and compliance with oxygen\ntherapy. The follow-up period is intended to last at least 3 years.\nDiscussion: The benefits of LTOT have been demonstrated whereas those of nocturnal oxygen therapy alone have\nnot. The INOX trial will likely determine whether supplemental oxygen during sleep is effective in reducing mortality,\ndelaying the need for LTOT and improving health-related quality of life in patients with COPD who desaturate overnight.
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