6/28/23, 11:01 PM LTOT Pathway Feedback Search Clinical Topics Home Studies LTOT LTOT Disease Disease Chronic obstructive pulmonary Dyspnea in palliative care Trial question What is the role of long-term supplemental oxygen in patients with stable COPD and resting or exercise-induced moderate desaturation? Study design Multi-center Open label RCT Population Characteristics of study participants 27.0% female N = 738 73.0% male 738 patients (196 female, 542 male) Inclusion criteria: patients with stable COPD who had moderate resting desaturation (SpO2 89- 93%) and moderate exercise-induced desaturation (during the 6-minute walk test, SpO2 80% for 5 minutes and < 90% for 10 seconds) Key exclusion criteria: COPD exacerbations requiring antibiotics, thoracic surgery or other procedures in the 6 months before randomization, non-COPD lung disease affecting oxygenation or survival, Epworth Sleepiness Scale score > 15, desaturation < 80% for at least 1 minute during the 6-minute walk, or disease or condition expected to cause death or inability to perform procedures within 6 months of randomization Interventions https://web.pathway.md/studies/recz8dh3ZorH2gtX8 1/2 6/28/23, 11:01 PM LTOT Pathway N=368 supplemental oxygen (long-term supplemental oxygen with 24-h oxygen for patients with resting desaturation and oxygen during exercise and sleep for patients with desaturation only during exercise) N=370 no supplemental oxygen (no long-term supplemental oxygen) Primary outcome Incidence of death or first hospitalization 36.4/100 py 36.4 34.2 27.3/100 py 18.2/100 py 9.1/100 py No significant difference 0.0/100 py Supplemental oxygen No supplemental oxygen No significant difference in the incidence of death or first hospitalization (36.4 /100 py vs. 34.2 /100 py; HR 1.06, 95% CI 0.89 to 1.26) Secondary outcomes No significant difference in the incidence of death (5.7 /100 py vs. 5.2 /100 py; HR 1.11, 95% CI 0.8 to 1.56) No significant difference in the incidence of hospitalization (34.5 /100 py vs. 31.6 /100 py; HR 1.09, 95% CI 0.9 to 1.29) Safety outcomes Significant difference in adverse events (51 vs. 0). Conclusion In patients with stable COPD who had moderate resting desaturation (SpO2 89-93%) and moderate exercise-induced desaturation (during the 6-minute walk test, SpO2 80% for 5 minutes and < 90% for 10 seconds), supplemental oxygen was not superior to no supplemental oxygen with respect to the incidence of death or first hospitalization. Reference Long-Term Oxygen Treatment Trial Research Group, Albert RK, Au DH et al. A Randomized Trial of Long-Term Oxygen for COPD with Moderate Desaturation. N Engl J Med. 2016 Oct 27;375(17):1617-1627. Open reference URL https://web.pathway.md/studies/recz8dh3ZorH2gtX8 2/2