Clinical trial NCT03984188: Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD
Official title: Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
COPD Exacerbation
COPD Exacerbation Acute
Pollution Related Respiratory Disorder
Pollution; Exposure
Keywords: Biomass Associated COPD
Low-dose Theophylline
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 40 years
2. Full-time resident of study area
3. Post-bronchodilator FEV1/FVC \< the lower limit of normal of the Global Lung Initiative Mixed Ethnic reference population
4. Grade B-D COPD
5. Daily biomass exposure

Exclusion Criteria:

1. Plans to move within one year
2. Uncontrolled hypertension
3. Pregnancy (assessed by urine pregnancy test among women of childbearing age/menstrual history)
4. Current use of chronic respiratory medications (Long acting Beta 2 Antagonists (LABA), Long-acting muscarinic antagonist (LAMA), inhaled corticosteroid (ICS))
5. History of post-treatment pulmonary tuberculosis
6. ≥10 pack year tobacco smoking history
7. Known intolerance or contraindication to theophylline.

Primary outcomes:
measure: Change in St. George Respiratory Questionnaire (SGRQ) Scores
timeFrame: Baseline, 1 year
Secondary outcomes:
measure: Change in Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline, 1 year
measure: Change in Forced Vital Capacity (FVC)
timeFrame: Baseline, 1 year
measure: Change in Forced Vital Capacity (FVC)
timeFrame: Baseline, 6 months
measure: Change in St. George Respiratory Questionnaire (SGRQ) Scores
timeFrame: Baseline, 6 months
measure: Change in Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere Lung Institute
city: Nakaseke
country: Uganda
facility: Nakaseke Hospital
Study officials:
affiliation: University of Miami
name: Trishul Siddharthan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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