Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Multi-Center Randomized Placebo-controlled Trial of Nocturnal Oxygen Therapy in Chronic Obstructive Pulmonary Disease. The International Nocturnal Oxygen (INOX) Trial
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.
Background Long-term oxygen therapy (LTOT) is the only component of the management of chronic
obstructive pulmonary disease (COPD) that improves survival in patients with severe daytime
hypoxemia (defined as an arterial oxygen pressure [PaO2] measured in stable state <= 55 mmHg
or in the range 56-59 mmHg when clinical evidence of pulmonary hypertension or polycythemia
are noted). In Canada, LTOT is usually provided by a stationary oxygen concentrator and is
recommended to be used for at least 15-18 hours a day. Several studies have demonstrated a
deterioration in arterial blood gas pressures and oxygen saturation during sleep in patients
with COPD. Sleep-related oxygen desaturation often occurs in patients not qualifying for
LTOT. The suggestion has been made that the natural progression of COPD to its end stages of
chronic pulmonary hypertension, severe hypoxemia, right heart failure, and death is dependent
upon the severity of desaturation occurring during sleep. This is an attractive hypothesis
and is supported by the fact that hypoxemic episodes during sleep are accompanied by
substantial increases in pulmonary arterial pressure and often by important cardiac
arrhythmias. Supplemental nocturnal oxygen alleviates both the acute increases in pulmonary
arterial pressure and the cardiac arrhythmias. It has been suggested that, over the long run,
nocturnal oxygen therapy (N-O2) may halt the progression of long-standing cor pulmonale and
prolong survival. Probably due to the fact that the recommendations of scientific societies
regarding the indications for and use of N-O2 in COPD not qualifying for conventional LTOT
are presently imprecise, a number of patients are currently treated with N-O2 although the
beneficial effects of this therapy have not been confirmed.
Objectives Primary objective: To determine, in patients with COPD not qualifying for LTOT but
who present significant nocturnal arterial oxygen desaturation, whether N-O2 provided for a
period of 4 years decreases mortality or delay the prescription of LTOT.
Secondary objectives: To estimate, in the same population, the cost-utility ratio of
nocturnal oxygen therapy over a 4-year period.
Hypotheses In patients with COPD not qualifying for LTOT but who present significant
nocturnal arterial oxygen desaturation, N-O2 provided for a period of 4 years is effective in
decreasing mortality or delaying the requirement for LTOT; and is cost-effective and
favorably compares to other medical interventions.
Research plan Study design: We propose a 4-year, multi-center, placebo-controlled, randomized
trial of nocturnal oxygen therapy added to usual care in patients presenting sleep-related
oxygen desaturation who do not qualify for LTOT.
Inclusion criteria: (1) patients with a diagnosis of COPD supported by an history of past
smoking and obstructive disease with FEV1/FVC < 70%; (2) presence of mild-to-moderate daytime
hypoxemia with a daytime PaO2 in the range of 56-69 mmHg; (3) patients fulfilling our
definition of nocturnal oxygen desaturation: >= 30% of the recording time with transcutaneous
arterial oxygen saturation < 90% on two consecutive recordings.
Intervention:
Nocturnal oxygen therapy: N-O2 will be delivered overnight to allow the oxygen saturation to
be > 90%.
Placebo: The patients allocated in the control group will receive room air delivered by
defective concentrator. The comparison will be double blind.
Primary outcomes The primary outcomes of this trial are mortality from all cause or
requirement for LTOT (composite outcome).
Secondary outcomes Secondary outcomes will include quality of life and utility measures,
costs from a societal perspective and compliance with oxygen therapy. Trial duration: The
follow-up period lasts at least 4 years. We expect this trial to be completed within 8 years.
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