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

Sponsor
University of Miami (Other)
Overall Status
Recruiting
CT.gov ID
NCT03984188
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
110
Enrollment
2
Locations
2
Arms
34.2
Anticipated Duration (Months)
55
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Theophylline ER
  • Drug: Placebo oral tablet
  • Other: Standard of Care Treatment
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 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
Actual Study Start Date :
Feb 23, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

    Drug: Placebo oral tablet
    Manufactured methylcellulose placebo tablet taken orally daily

    Other: Standard of Care Treatment
    Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment

    Outcome Measures

    Primary Outcome Measures

    1. Change in St. George Respiratory Questionnaire (SGRQ) Scores [Baseline to 6 months, Baseline to 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

    1. Change in forced expiratory volume in one second (FEV1) [Baseline to 6 months, Baseline to 1 year]

      FEV1 (L) as measured through spirometry

    2. Change in forced vital capacity (FVC) [Baseline to 6 months, Baseline to 1 year]

      FVC (L) as measured through spirometry

    3. Change in peak expiratory flow (PEF) [Baseline to 6 months, Baseline to 1 year]

      PEF (L/min) as measured through spirometry

    4. Change in blood levels of high sensitivity C reactive protein (hs-CRP) [Baseline to 6 months, Baseline to 1 year]

      Blood levels of hs-CRP (mg/L)

    5. Change in blood levels of fibrinogen [Baseline to 6 months, Baseline to 1 year]

      Blood levels of fibrinogen (mg/dL)

    6. Change in Short Form 36 (SF-36) Questionnaire Scores [Baseline to 6 months, Baseline to 1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Makerere Lung Institute Kampala Uganda
    2 Nakaseke Hospital Nakaseke Uganda

    Sponsors and Collaborators

    • University of Miami
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Trishul Siddharthan, Assistant Professor of Clinical, University of Miami
    ClinicalTrials.gov Identifier:
    NCT03984188
    Other Study ID Numbers:
    • 20201523
    • 1K23HL146946-01
    • IRB00209008
    First Posted:
    Jun 12, 2019
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Trishul Siddharthan, Assistant Professor of Clinical, University of Miami
    Biomass Associated COPD
    Low-dose Theophylline
    Additional relevant MeSH terms:
    Pulmonary Disease, Chronic Obstructive
    Respiration Disorders
    Respiratory Tract Diseases
    Theophylline

    Study Results

    No Results Posted as of May 4, 2022