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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
200 mg extended release (ER) low-dose theophylline taken orally daily
Manufactured methylcellulose placebo tablet taken orally daily
Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment
Makerere Lung Institute
Kampala, Uganda
Nakaseke Hospital
Nakaseke, Uganda
Change in St. George Respiratory Questionnaire (SGRQ) Scores
The SGRQ comprises of 50 items and consists of two parts. The first part pertains to symptoms and the second pertains to functional status as well as social and psychological impact of disease. Overall scores ranges between 0 and 100 with higher scores indicating more limitations.
Time frame: Baseline, 1 year
Change in Forced Expiratory Volume in One Second (FEV1)
FEV1 measures how much air a person can exhale during a forced breath. The amount of air exhaled during the first second measured in liters.
Time frame: Baseline, 1 year
Change in Forced Vital Capacity (FVC)
FVC measures how much air a person can exhale at the end of a forced breath measured in liters.
Time frame: Baseline, 1 year
Change in Forced Vital Capacity (FVC)
FVC measures how much air a person can exhale at the end of a forced breath measured in liters.
Time frame: Baseline, 6 months
Change in St. George Respiratory Questionnaire (SGRQ) Scores
The SGRQ comprises of 50 items and consists of two parts. The first part pertains to symptoms and the second pertains to functional status as well as social and psychological impact of disease. Overall scores ranges between 0 and 100 with higher scores indicating more limitations.
Time frame: Baseline, 6 months
Change in Forced Expiratory Volume in One Second (FEV1)
FEV1 measures how much air a person can exhale during a forced breath. The amount of air exhaled during the first second measured in liters.
Time frame: Baseline, 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.