It was redesigned to utilize a composite primary outcome of time to either death or hospitalization for any cause. It was amended after seven months, as the trial’s design was deemed to be flawed due to lower-than-projected mortality. Initially, the trial was designed to assess whether LTOT would result in longer time to death compared to no oxygen therapy in patients with moderate desaturation, defined as a resting SpO 2 of 89-93%. With more patients than all previous LTOT trials combined, it is the largest trial ever to examine this therapy. 4 This multicenter, parallel-group, randomized, unblinded trial enrolled 738 patients. However, the 2016 Long Term Oxygen Treatment Trial has provided strong new evidence supporting the conclusions of these previous studies. 7,8 These two trials were not powered to assess mortality, but for many years were the only available evidence regarding LTOT in this population. 3 Gorecka and colleagues defined this as a PaO 2 of 56-65 mmHg in their inclusion criteria, and Haidl and colleagues, who studied the effect of LTOT on the decline of endurance in patients with reversible hypercapnea, included only patients with a PaO 2 >50 mmHg. The remaining trials did not demonstrate a mortality benefit for LTOT, but notably, these studies targeted patients with mild-to-moderate hypoxemia. The LTOT group had a significant improvement in 5-year mortality, with an impressive number needed to treat of 4.5. MRC was a UK trial of similar design that randomized patients with a PaO 2 between 40 and 60 mmHg and one or more episodes of heart failure with documented ankle edema to either LTOT or no oxygen therapy. At 24 months of oxygen therapy there was a significant decrease in mortality in the continuous oxygen arm of the trial. The 203 patients enrolled were randomized to continuous or nocturnal oxygen therapy. Enrolled patients were required to have PaO 2 ≤55 mmHg or PaO 2 ≤59 mmHg with edema, hematocrit ≥55%, or electrocardiographic evidence of cor pulmonale. 5,6 NOTT was a multicenter, parallel-group, open-label, randomized controlled trial. The Nocturnal Oxygen Therapy Trial (NOTT) and MRC Working Party Trial (MRC), from 19 respectively, are the only trials to show a survival benefit for LTOT in COPD. 3,4 Of these, five trials examine the administration of LTOT. There are seven randomized clinical trials that currently inform our administration of oxygen therapy.
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