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Effectiveness of Low-dose Theophylline for the Management of Biomass-associated COPD in Uganda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03984188
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
COPD COPD Exacerbation COPD Exacerbation Acute Pollution Related Respiratory Disorder Pollution; Exposure Drug: Theophylline ER Drug: Placebo oral tablet Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Low-dose Theophylline for the Management of Biomass-associated COPD
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Low-dose Theophylline
Participant in this group will receive low-dose theophylline.
Drug: Theophylline ER
250mg ER low-dose theophylline taken orally daily
Other Name: Low-dose Theophylline

Placebo Comparator: Placebo
Participant in this group will receive a placebo.
Drug: Placebo oral tablet
Manufactured placebo tablet taken orally daily

Primary Outcome Measures :
  1. Change in St. George Respiratory Questionnaire score (SGRQ) [ Time Frame: Baseline, 6 months, 1 year ]
    The St. George Respiratory Questionnaire score 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.

  2. Cost-Effectiveness as assessed by the Short Form 36 (SF-36) [ Time Frame: 1 year ]
    Incremental cost-effectiveness using the Short From 36 score comprising 36 items. The SF-36 consists of eight scaled domains (vitality, physical functioning, body pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) each transformed into a 0-100 scale. Lower scores signify higher levels of disability.

Secondary Outcome Measures :
  1. Change in forced expiratory volume in one second (FEV1) [ Time Frame: Baseline, 6 months, 1 year ]
    FEV1 (L) as measured through spirometry

  2. Change in forced vital capacity (FVC) [ Time Frame: Baseline, 6 months, 1 year ]
    FVC (L) as measured through spirometry

  3. Change in peak expiratory flow (PEF) [ Time Frame: Baseline, 6 months, 1 year ]
    PEF (L/min) as measured through spirometry

  4. Change in blood levels of high sensitivity C reactive protein (hs-CRP) [ Time Frame: Baseline, 6 months, 1 year ]
    Blood levels of hs-CRP (mg/L)

  5. Change in blood levels of fibrinogen [ Time Frame: Baseline, 6 months, 1 year ]
    Blood levels of fibrinogen (mg/dL)

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 40 years;
  • Full-time resident of Nakaseke, Uganda
  • post-bronchodilator FEV1/FVC < the lower limit of normal of the Global Lung Initiative Mixed Ethnic reference population
  • Grade B-D COPD; 5) Daily biomass exposure

Exclusion Criteria:

  • Plans to move out of the study area within one year
  • Uncontrolled hypertension
  • Pregnancy
  • Current use of chronic respiratory medications [Long-acting beta-adrenoceptor agonist (LABA), Long-acting muscarinic antagonists (LAMA), inhaled corticosteroids (ICS)]
  • History of post-treatment pulmonary tuberculosis
  • ≥10 pack year tobacco smoking history
  • Known intolerance or contraindication to theophylline.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03984188

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Contact: Trishul Siddharthan, MD (410) 955-3467
Contact: Phabiola Herrera, MD 443.287.1971

Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: William Checkley Johns Hopkins University


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Responsible Party: Johns Hopkins University Identifier: NCT03984188     History of Changes
Other Study ID Numbers: IRB00209008
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Johns Hopkins University:
Biomass Associated COPD
Low-dose Theophylline
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents