Randomized Trial of Nocturnal Oxygen in Chronic Obstructive Pulmonary Disease.

BACKGROUND: Long-term oxygen therapy improves survival in patients with chronic obstructive pulmonary disease (COPD) and chronic severe daytime hypoxemia. However, the efficacy of oxygen therapy for the management of isolated nocturnal hypoxemia is uncertain. METHODS: We designed this double-blind, placebo-controlled, randomized trial to determine, in patients with COPD who have nocturnal arterial oxygen desaturation without qualifying for long-term oxygen therapy, whether nocturnal oxygen provided for a period of 3 to 4 years would decrease mortality or the worsening of disease such that patients meet current specifications for long-term oxygen therapy. Patients with an oxygen saturation of less than 90% for at least 30% of the recording time on nocturnal oximetry were assigned, in a 1:1 ratio, to receive either nocturnal oxygen or ambient air from a sham concentrator (placebo). The primary outcome was a composite of death from any cause or a requirement for long-term oxygen therapy as defined by the Nocturnal Oxygen Therapy Trial (NOTT) criteria in the intention-to-treat population. RESULTS: Recruitment was stopped prematurely because of recruitment and retention difficulties after 243 patients, of a projected 600, had undergone randomization at 28 centers. At 3 years of follow-up, 39.0% of the patients assigned to nocturnal oxygen (48 of 123) and 42.0% of those assigned to placebo (50 of 119) met the NOTT-defined criteria for long-term oxygen therapy or had died (difference, -3.0 percentage points; 95% confidence interval, -15.1 to 9.1). CONCLUSIONS: Our underpowered trial provides no indication that nocturnal oxygen has a positive or negative effect on survival or progression to long-term oxygen therapy in patients with COPD. (Funded by the Canadian Institutes of Health Research; INOX ClinicalTrials.gov number, NCT01044628.).

Short-Term Oxygen Therapy Outcomes in COPD.

Rationale: Short-term oxygen therapy (STOT) is often prescribed to allow patients with chronic obstructive pulmonary disease (COPD) to be discharged safely from hospital following an acute illness. This practice is widely accepted without being based on evidence. Purpose: Our objective was to describe the characteristics and outcomes of patients with COPD who received STOT. Patients and Methods: The study was a secondary analysis of the INOX trial, a 4-year randomised trial of nocturnal oxygen in COPD. The trial indicated that nocturnal oxygen has no significant effect on survival or progression to LTOT, allowing our merging of patients who received nocturnal oxygen and those who received placebo into a single cohort to study the predictors and outcomes of STOT regardless of the treatment received during the trial. Results: Among the 243 participants in the trial, 60 required STOT on at least one occasion during follow-up. Patients requiring STOT had more severe dyspnoea and lung function impairment, and lower PaO2 at baseline than those who did not. STOT was associated with subsequent LTOT requirement (hazard ratio [HR]: 4.59; 95% confidence interval [CI]: 2.98-7.07) and mortality (HR: 1.93; 95% CI: 1.15-3.24). The association between STOT and mortality was confounded by age, disease severity and comorbidities. Periods of STOT of more than one month and/or repeated prescriptions of STOT increased the probability of progression to LTOT (OR: 5.07; 95% CI: 1.48-18.8). Conclusion: Following an acute respiratory illness in COPD, persistent hypoxaemia requiring STOT is a marker of disease progression towards the requirement for LTOT.