Abstract Rationale Most chronic obstructive pulmonary disease (COPD) morbidity and mortality occur in low- and middle-income countries (LMICs), where biomass exposure is the predominant risk factor rather than cigarette smoking. However, few studies have assessed pharmacological treatment effectiveness in biomass-associated COPD within these regions. In LMICs, theophylline is an affordable and widely available bronchodilator with unknown therapeutic benefit when utilized at low doses. The objective of this study was to understand heterogeneity of theophylline treatment effect among individuals with biomass-associated COPD in a low-dose theophylline trial. Methods Post-hoc analysis of a pilot randomized controlled trial performed in Uganda in patients with GOLD B-D COPD and daily biomass exposure was performed. A randomized intervention group (n = 50) received low-dose theophylline (200 mg daily), while the control group (n = 50) received placebo. Baseline data included demographics, lung function, St. George’s Respiratory Questionnaire (SGRQ) scores, and body mass index (BMI). Response was defined based upon changes in SGRQ scores and post-bronchodilator forced expiratory volume in 1 second (FEV1), assessed via spirometry. Characteristics of responders were compared to non-responders using qualitative and quantitative analysis. Results Of the 50 patients in the theophylline arm, 11 participants (22%) died (n = 2), withdrew (n = 6), or were lost to follow up (n = 3) Meanwhile, 8 participants (16%) died (n = 4) or withdrew (n = 4) within the control group of 50 patients. At 12 months, mean total SGRQ scores were lower with theophylline compared to controls (39.02 vs. 45.06; p = 0.08, 80% one-sided CI), although changes in FEV1 were not significantly different. Among 6-month responders (n = 37), female sex was significantly more frequent compared to non-responders (n = 7; p = 0.05). Baseline symptoms, lung function, BMI, and SGRQ were not different between experimental groups. Most responders (n = 34) also demonstrated concomitant improvement in lung function. Conclusions Low-dose theophylline may improve symptoms in biomass-associated COPD with response being higher in subgroups, particularly among women. These findings support the need for further prospective studies to confirm long-term theophylline responders. Ultimately, improving access to effective treatments in LMICs remains essential to pulmonary global health. This abstract is funded by: None
Brann et al. (Fri,) studied this question.
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