NOTT
Trial question
What is the role of continuous oxygen therapy in patients with COPD and hypoxemia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 203
203 patients (43 female, 160 male).
Inclusion criteria: patients with COPD and hypoxemia.
Key exclusion criteria: previous oxygen therapy, other disease that might influence morbidity, mortality, compliance with therapy, or ability to give informed consent.
Interventions
N=101 continuous oxygen therapy (by nasal prong at a measured flow rate of 1-4 L/min continuously for at least 12 months).
N=102 nocturnal oxygen therapy (by nasal prong at a measured flow rate of 1-4 L/min at an interval of 12 hours for at least 12 months).
Primary outcome
Death at 1 year
11.9%
20.6%
20.6 %
15.5 %
10.3 %
5.2 %
0.0 %
Continuous oxygen
therapy
Nocturnal oxygen
therapy
Significant
decrease ▼
NNT = 11
Significant decrease in death at 1 year (11.9% vs. 20.6%; HR 0.52, 95% CI 0.31 to 0.85).
Secondary outcomes
Significant decrease in death, in patients with PaCO2 ≥ 43 mmHg (19.6% vs. 46%; RR 0.43, 95% CI 0.16 to 0.7).
Conclusion
In patients with COPD and hypoxemia, continuous oxygen therapy was superior to nocturnal oxygen therapy with respect to death at 1 year.
Reference
Nocturnal Oxygen Therapy Trial Group. Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8.
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