A Randomized Trial of Long-Term Oxygen for COPD with Moderate Desaturation. Academic Article Article uri icon

Overview

MeSH

  • Aged
  • Exercise
  • Exercise Tolerance
  • Female
  • Follow-Up Studies
  • Hospitalization
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Patient Compliance
  • Quality of Life
  • Time Factors
  • Treatment Failure

MeSH Major

  • Oxygen
  • Oxygen Inhalation Therapy
  • Pulmonary Disease, Chronic Obstructive

abstract

  • Background 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. Methods We originally designed the trial to test whether long-term treatment with supplemental oxygen would result in a longer time to death than no use of supplemental oxygen among patients who had stable COPD with moderate resting desaturation (oxyhemoglobin saturation as measured by pulse oximetry [Spo2], 89 to 93%). After 7 months and the randomization of 34 patients, the trial was redesigned to also include patients who had stable COPD with moderate exercise-induced desaturation (during the 6-minute walk test, Spo2 ≥80% for ≥5 minutes and <90% for ≥10 seconds) and to incorporate the time to the first hospitalization for any cause into the new composite primary outcome. Patients were randomly assigned, in a 1:1 ratio, to receive long-term supplemental oxygen (supplemental-oxygen group) or no long-term supplemental oxygen (no-supplemental-oxygen group). In the supplemental-oxygen group, patients with resting desaturation were prescribed 24-hour oxygen, and those with desaturation only during exercise were prescribed oxygen during exercise and sleep. The trial-group assignment was not masked. Results A total of 738 patients at 42 centers were followed for 1 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, 0.94; 95% confidence interval [CI], 0.79 to 1.12; P=0.52), nor in the rates of all hospitalizations (rate ratio, 1.01; 95% CI, 0.91 to 1.13), COPD exacerbations (rate ratio, 1.08; 95% CI, 0.98 to 1.19), and COPD-related hospitalizations (rate ratio, 0.99; 95% CI, 0.83 to 1.17). We found no consistent between-group differences in measures of quality of life, lung function, and the distance walked in 6 minutes. Conclusions In patients with stable COPD and resting or exercise-induced moderate desaturation, the prescription of long-term supplemental oxygen did not result in a longer time to death or first hospitalization than no long-term supplemental oxygen, nor did it provide sustained benefit with regard to any of the other measured outcomes. (Funded by the National Heart, Lung, and Blood Institute and the Centers for Medicare and Medicaid Services; LOTT ClinicalTrials.gov number, NCT00692198 .).

publication date

  • October 27, 2016

has subject area

  • Aged
  • Exercise
  • Exercise Tolerance
  • Female
  • Follow-Up Studies
  • Hospitalization
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Oxygen
  • Oxygen Inhalation Therapy
  • Patient Compliance
  • Pulmonary Disease, Chronic Obstructive
  • Quality of Life
  • Time Factors
  • Treatment Failure

Research

keywords

  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial

Identity

Language

  • eng

PubMed Central ID

  • PMC5216457

Digital Object Identifier (DOI)

  • 10.1056/NEJMoa1604344

PubMed ID

  • 27783918

Additional Document Info

start page

  • 1617

end page

  • 1627

volume

  • 375

number

  • 17