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

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ClinicalTrials.gov Identifier: NCT03984188
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 12, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Change in forced expiratory volume in one second (FEV1) [ Time Frame: Baseline, 6 months, 1 year ]
    FEV1 (L) as measured through spirometry
  • Change in forced vital capacity (FVC) [ Time Frame: Baseline, 6 months, 1 year ]
    FVC (L) as measured through spirometry
  • Change in peak expiratory flow (PEF) [ Time Frame: Baseline, 6 months, 1 year ]
    PEF (L/min) as measured through spirometry
  • 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)
  • Change in blood levels of fibrinogen [ Time Frame: Baseline, 6 months, 1 year ]
    Blood levels of fibrinogen (mg/dL)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Low-dose Theophylline for the Management of Biomass-associated COPD in Uganda
Official Title  ICMJE Effectiveness of Low-dose Theophylline for the Management of Biomass-associated COPD
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • COPD Exacerbation
  • COPD Exacerbation Acute
  • Pollution Related Respiratory Disorder
  • Pollution; Exposure
Intervention  ICMJE
  • Drug: Theophylline ER
    250mg ER low-dose theophylline taken orally daily
    Other Name: Low-dose Theophylline
  • Drug: Placebo oral tablet
    Manufactured placebo tablet taken orally daily
Study Arms  ICMJE
  • Experimental: Low-dose Theophylline
    Participant in this group will receive low-dose theophylline.
    Intervention: Drug: Theophylline ER
  • Placebo Comparator: Placebo
    Participant in this group will receive a placebo.
    Intervention: Drug: Placebo oral tablet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trishul Siddharthan, MD (410) 955-3467 tsiddhar@hotmail.com
Contact: Phabiola Herrera, MD 443.287.1971 pherrer2@jhmi.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984188
Other Study ID Numbers  ICMJE IRB00209008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William Checkley Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP