# Effectiveness of Low-dose Theophylline for the Management of biomass-associated COPD

> **NIH NIH K23** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2021 · $196,555

## Abstract

PROJECT SUMMARY/ABSTRACT
This is an application for the K23 Mentored Patient-Oriented Research Career Scientist Award for Trishul
Siddharthan M.D. Dr. Siddharthan has shown great promise as a young investigator, and has experience
conducting research in epidemiology and chronic disease in low- and middle-income countries (LMICs).
However, he is now proposing to gain advanced training in conducting longitudinal analysis and randomized
controlled trials requires additional training and mentorship to do so. His overall career goal is to become an
independent investigator and expert in evaluating the effectiveness medical therapies for chronic respiratory
diseases, and this award will provide Dr. Siddharthan with the support and training to accomplish this goal. He
has assembled an experienced mentorship team including: Dr. William Checkley (Primary Mentor, Chronic
Respiratory Diseases), Associate Professor (JHU); Dr. Robert Wise (Clinical Trials), Professor (JHU); Dr.
James Tonascia (Biostatistics), Professor (JHU); and Dr. David Dowdy (Cost-evaluation), Associate Professor
(JHU). Through a combination of close mentorship, formal coursework, and practical experience, Dr.
Siddharthan proposes to accomplish the following training goals: 1) Advanced training in longitudinal analysis;
2) Advanced training in randomized controlled trials; and 3) Advanced training in cost-evaluation.
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. Dr. Siddharthan
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 Peru. He proposes 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. He 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. Results from this study will generate
preliminary data to compete for an R01-level award to conduct an implementation-effectiveness hybrid trial in
multiple communities to assess the impact of chronic pharmacotherapy for biomass-related COPD.

## Key facts

- **NIH application ID:** 10360262
- **Project number:** 7K23HL146946-03
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** Trishul Siddharthan
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $196,555
- **Award type:** 7
- **Project period:** 2019-07-15 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10360262

## Citation

> US National Institutes of Health, RePORTER application 10360262, Effectiveness of Low-dose Theophylline for the Management of biomass-associated COPD (7K23HL146946-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10360262. Licensed CC0.

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