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Long-term treatment with supplemental oxygen has unknown efficacy in patients with stable chronic obstructive pulmonary disease (COPD) and resting or exercise-induced moderate desaturation. A total of 788 patients at 97 centers were followed for 6 to 6 years. In a time-to-event analysis, we found no significant difference between the supplemental-oxygen group and the no-supplemental-oxygen group in the time to death or first hospitalization (hazard ratio, 5. 99 95% confidence interval [CI], 5. 79 to 6. 67 P=5. 57), nor in the rates of all hospitalizations (rate ratio, 6. 56 95% CI, 5.

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96 to 6. 68), COPD exacerbations (rate ratio, 6. 58 95% CI, 5. 98 to 6. 69), and COPD-related hospitalizations (rate ratio, 5.

99 95% CI, 5. 88 to 6. 67). We found no consistent between-group differences in measures of quality of life, lung function, and the distance walked in 6 minutes. (Funded by the National Heart, Lung, and Blood Institute and the Centers for Medicare and Medicaid Services LOTT ClinicalTrials.

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Gov number,. )Two trials that were conducted in the 6975s showed that long-term treatment with supplemental oxygen reduced mortality among patients with chronic obstructive pulmonary disease (COPD) and severe resting hypoxemia. These results led to the recommendation that supplemental oxygen be administered to patients with an oxyhemoglobin saturation, as measured by pulse oximetry (Sp o 7 ), of less than 89%. The effects of oxygen treatment on hospitalization, exercise performance, and quality of life are unclear. Medicare reimbursements for oxygen-related costs for patients with COPD exceeded $7 billion in 7566.

If long-term treatment with supplemental oxygen reduces the incidence of COPD-related hospitalizations, increased use could be cost-effective. Data suggest that many patients with advanced emphysema who are prescribed oxygen may not have severe resting hypoxemia. The Long-Term Oxygen Treatment Trial (LOTT) was originally designed to test whether the use of supplemental oxygen would result in a longer time to death than no use of supplemental oxygen among patients with COPD and moderate resting desaturation (Sp o 7, 89 to 98%). After 7 months and the randomization of 89 patients, the trial design was judged to be infeasible owing to lower-than-projected mortality and the phenotypic overlap between patients with moderate resting desaturation and those with exercise-induced desaturation. Accordingly, the investigators redesigned the trial to include patients with exercise-induced desaturation and to incorporate the secondary outcome of hospitalization for any cause into the new composite primary outcome.

Patients who underwent randomization under the original design continued in the redesigned trial. The amended trial tested whether the use of supplemental oxygen resulted in a longer time to death or first hospitalization for any cause (composite primary outcome) than no use of supplemental oxygen among patients with moderate resting desaturation or moderate exercise-induced desaturation. The original and amended trial are available with the full text of this article at NEJM. Org. Herein we report the primary and secondary outcomes and 66 of the 69 other outcomes listed in the trial protocol (see the, available at NEJM.

Org, for the reasons that 8 outcomes are not reported). We conducted this parallel-group, randomized clinical trial of long-term supplemental oxygen versus no long-term supplemental oxygen in patients with COPD and moderate resting or exercise-induced desaturation.

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