Low-dose theophylline in mild to moderate Chronic Obstructive Pulmonary Disease: A randomized clinical trial in China.
Yumin Zhou, Cuiqiong Dai, Fan Wu et al.
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In 30 seconds
This multicentre, randomised, double-blind, placebo-controlled trial in China assessed low-dose sustained-release theophylline in people with mild to moderate COPD. Participants received theophylline 100 mg twice daily or placebo for 12 months; 734 were randomised and 615 completed the study. At month 12, pre-bronchodilator FEV₁ was 30 ml higher with theophylline than placebo (95% CI, 3 to 57 ml; p = 0.031). Annual exacerbation rates did not differ significantly, and adverse-event incidence was comparable. The authors describe the lung-function improvement as modest and conclude that treatment did not reduce exacerbations.
Key findings
- At month 12, pre-bronchodilator FEV₁ was 30 ml higher with theophylline than placebo (95% CI, 3 to 57 ml; p = 0.031).
- Annual exacerbation rates were 0.46 ± 0.03 vs 0.43 ± 0.04 per patient-year (RR, 1.07 [95% CI, 0.84 to 1.36]; p = 0.607).
- Adverse-event incidence was comparable between the theophylline and placebo groups.
Why it matters
The trial addresses uncertainty about low-dose theophylline in mild to moderate COPD. Its findings distinguish a modest improvement in pre-bronchodilator lung function from an absence of demonstrated exacerbation reduction, helping clinicians interpret the potential benefit without overstating its clinical impact. Comparable adverse-event incidence provides tolerability information over the 12-month study period.
What to keep in mind
615 of 734 randomised participants completed the study. The observed FEV₁ improvement was modest, and the between-group difference in mean change from baseline was not statistically significant (p = 0.063).