Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide,
and over 90% of COPD-related deaths occurring in low- and middle-income countries (LMICs).
Household air pollution (HAP) - from burning solid fuels such as wood, dung, agricultural
crop waste, and coal for energy - is the primary risk factor for COPD in these settings.
Biomass-related COPD has a distinct histopathology, phenotype and inflammatory profile when
compared to tobacco mediated COPD. Despite the high global burden of biomass-related disease,
little is known about the effectiveness of pharmacotherapies for biomass-related COPD; to
date, no clinical trials have focused specifically on treatment of biomass-related COPD. This
study proposes to assess the health impact of biomass-related COPD and test the effectiveness
of low dose theophylline compared to standard therapy among adults with biomass-related COPD
in Uganda with the aim to assess whether low-dose theophylline improves respiratory symptoms,
decreases the inflammatory profile of serum biomarkers and whether administration attenuates
the effect of HAP on lung function. The study additionally aims to assess whether low-dose
theophylline is a cost-effective intervention based on the incremental cost-effectiveness
ratio and a range of willingness to pay thresholds.