LTOT
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
73.0% male
N = 738
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
N=368 supplemental oxygen (long-term supplemental oxygen with 24-hour 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
34.2
36.4/100 py
27.3/100 py
18.2/100 py
9.1/100 py
0.0/100 py
Supplemental
oxygen
No supplemental
oxygen
No significant
difference ↔
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.
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