NCT03984188CompletedPhase 3
Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD
Source: ClinicalTrials.gov · Last updated 15 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 10 Jun 2019
- Start date
- 23 Feb 2021
- Primary completion date
- 17 Oct 2023
- Lead sponsor
- University of Miami
- Diseases
- COPD
- NCT number
- NCT03984188
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 100
- From 23 Feb 2021 to the primary completion date, 17 Oct 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of chronic respiratory medications (Long acting Beta 2 Antagonists (LABA), Long-acting muscarinic antagonist (LAMA), inhaled corticosteroid (ICS))
Other illness
- Uncontrolled hypertension
- History of post-treatment pulmonary tuberculosis
Age
- Pregnancy (assessed by urine pregnancy test among women of childbearing age/menstrual history)
Other
- Plans to move within one year
- ≥10 pack year tobacco smoking history
- Known intolerance or contraindication to theophylline.
Who the study is looking for
- Age ≥ 40 years
- Full-time resident of study area
- Post-bronchodilator FEV1/FVC \< the lower limit of normal of the Global Lung Initiative Mixed Ethnic reference population
- Grade B-D COPD
- Daily biomass exposure
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Makerere Lung Institute Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| Nakaseke Hospital Coordinator of this site? Confirm its status | Nakaseke | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.