Skip to main content
OpenTrials
Completed

NCT Number: NCT03984188

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD COPD Exacerbation COPD Exacerbation Acute Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pollution Related Respiratory Disorder Pollution; Exposure Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Makerere Lung Institute, Kampala, Uganda

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Theophylline ER

Drug

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

Other names: Low-dose Theophylline

Placebo oral tablet

Drug

Manufactured methylcellulose placebo tablet taken orally daily

Standard of Care Treatment

Other

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

Primary outcomes

  1. Change in St. George Respiratory Questionnaire (SGRQ) Scores

    Time frame: 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 outcomes

  1. Change in Forced Expiratory Volume in One Second (FEV1)

    Time frame: Baseline, 1 year

    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.

  2. Change in Forced Vital Capacity (FVC)

    Time frame: Baseline, 1 year

    FVC measures how much air a person can exhale at the end of a forced breath measured in liters.

  3. Change in Forced Vital Capacity (FVC)

    Time frame: Baseline, 6 months

    FVC measures how much air a person can exhale at the end of a forced breath measured in liters.

  4. Change in St. George Respiratory Questionnaire (SGRQ) Scores

    Time frame: 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.

  5. Change in Forced Expiratory Volume in One Second (FEV1)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2019
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.