Trials / Completed
CompletedNCT03984188
Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- University of Miami · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- COPD
- COPD Exacerbation
- COPD Exacerbation Acute
- Pollution Related Respiratory Disorder
- Pollution; Exposure
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Theophylline ER | 200 mg extended release (ER) low-dose theophylline taken orally daily |
| DRUG | Placebo oral tablet | Manufactured methylcellulose placebo tablet taken orally daily |
| OTHER | Standard of Care Treatment | Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment |
Timeline
- Start date
- 2021-02-23
- Primary completion
- 2023-10-17
- Completion
- 2023-12-15
- First posted
- 2019-06-12
- Last updated
- 2024-11-15
- Results posted
- 2024-10-29
Locations
2 sites across 1 country: Uganda
Source: ClinicalTrials.gov record NCT03984188. Inclusion in this directory is not an endorsement.