CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Theophylline ER +2 moredrug
Likely dose
Theophylline ER 200 mgfrom record
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Search/NCT03984188
NCT03984188Phase 3Completed

Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD

University of Miami·interventional·Posted Jun 12, 2019·Updated Nov 15, 2024

In Brief

A Phase 3 clinical trial evaluating Theophylline ER, Placebo oral tablet, and 1 other intervention for COPD and 4 related conditions. Completed, enrolled 100 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUganda

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 12, 2019
Enrollment StartFeb 23, 2021
Primary CompletionOct 17, 2023
Study CompletionDec 15, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.1 years ago

Interventions

Theophylline ERdrug

200 mg extended release (ER) low-dose theophylline taken orally daily

Placebo oral tabletdrug

Manufactured methylcellulose placebo tablet taken orally daily

Standard of Care Treatmentother

Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment