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

October 29, 2024 updated by: Trishul Siddharthan, University of Miami
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Makerere Lung Institute
      • Nakaseke, Uganda
        • Nakaseke Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-dose Theophylline Group
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.
Drug: Theophylline ER
200 mg extended release (ER) low-dose theophylline taken orally daily
Other Names:
  • Low-dose Theophylline
Other: Standard of Care Treatment
Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment
Placebo Comparator: Placebo Group
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.
Other: Standard of Care Treatment
Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment
Drug: Placebo oral tablet
Manufactured methylcellulose placebo tablet taken orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 year
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.
Baseline, 1 year
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.
Baseline, 6 months
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.
Baseline, 6 months
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.
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Trishul Siddharthan, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Actual)

October 17, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 11, 2019

First Posted (Actual)

June 12, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20201523
  • 1K23HL146946-01 (U.S. NIH Grant/Contract)
  • IRB00209008 (Other Identifier: Johns Hopkins University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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