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

Phase 3

Completed

• Conditions: COPD Exacerbation; Pollution; Exposure; Pollution Related Respiratory Disorder; COPD; COPD Exacerbation Acute
• Interventions: Drug: Theophylline ER; Drug: Placebo oral tablet; Other: Standard of Care Treatment

• Registration Number: NCT03984188
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-12
• Study Start: 2021-02-23
• Primary Completion: 2023-10-17
• Study Completion: 2023-12-15
• Status Verified: 2024-10
• Results First Submitted: 2024-10-03
• Results First Submitted QC: 2024-10-03
• Results First Posted: 2024-10-29
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose Theophylline Group	Theophylline ER	Participant in this group will receive low-dose theophylline in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment, over a one year period.
Placebo Group	Placebo oral tablet	Participant in this group will receive a placebo in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment.
Placebo Group	Standard of Care Treatment	Participant in this group will receive a placebo in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment.
Low-dose Theophylline Group	Standard of Care Treatment	Participant in this group will receive low-dose theophylline in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment, over a one year period.

Primary Outcome Measures

Name	Time	Method
Change in St. George Respiratory Questionnaire (SGRQ) Scores	Baseline, 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Change in Forced Expiratory Volume in One Second (FEV1)	Baseline, 6 months	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.
Change in Forced Vital Capacity (FVC)	Baseline, 6 months	FVC measures how much air a person can exhale at the end of a forced breath measured in liters.
Change in St. George Respiratory Questionnaire (SGRQ) Scores	Baseline, 6 months	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.

Trial Locations

Locations (2)

Makerere Lung Institute; 🇺🇬 Kampala, Uganda

Nakaseke Hospital; 🇺🇬 Nakaseke, Uganda