# Research Project 3: Respiratory health effects of flavors

> **NIH NIH U54** · ROSWELL PARK CANCER INSTITUTE CORP · 2020 · $431,903

## Abstract

Project 3 addresses the Center for Tobacco Products (CTP) research priorities under Health Effects scientific
domain as defined in RFA-OD-17-006, and the overarching integrative scientific theme of this TCORS
coalesce for testing the effects of flavorings in tobacco products and characterize their respiratory
toxicity. Many of the flavorings chemicals being used in emerging tobacco products, including electronic
nicotine delivery system (ENDS), waterpipe tobacco and cigarillos, were evaluated for safety through ingestion
only. These flavorings have not been tested adequately for safety when inhaled in aerosolized form. At
present, no regulatory program exists to assess the respiratory health hazards of the flavorings in tobacco
products. This project will focus primarily on respiratory health effects, including inflammation, biomarkers of
exposure, and clinical markers with relevance to disease endpoints that will directly supports the Toxicity
scientific domain. Embedded within these health effects studies, we will of necessity gather data on product
usage patterns that may influence health effects, including total consumption, topography, and flavor
preference, which will help inform the Behavior scientific domain. We propose to test the hypotheses that
inhalation of flavored ENDS aerosol has the potential to cause chronic respiratory tract inflammation, and that
potential inflammatory effects and observed respiratory side-effects associated with flavored ENDS use will
depend on the specific flavoring chemicals used in the products and the patterns of products use. Our goal is
to better characterize the respiratory health effects attributable to the use of flavored tobacco products. We
propose two human studies to evaluate respiratory health effects from inhaling flavored products among daily
ENDS users as they switch among various flavors. These two studies aim to: AIM 1 (Study 1): Assess
changes in respiratory symptoms and biomarker levels among ENDS users during spontaneous `switching'
between flavors; AIM 2 (Study 2): Evaluate respiratory symptoms in ENDS users switching from flavors of
potentially high-toxicity to flavors of potentially low-toxicity; and AIM 3 (Studies 1&2): Characterize ENDS
users' preferences, selection, patterns of use and switching between various flavors. In Study 1, we will
establish a cohort of ENDS users to assess changes in respiratory symptoms during spontaneous `switching'
among flavors over one year. In Study 2, we will conduct a randomized, parallel-group open-label trial to
evaluate respiratory symptoms in ENDS users switching from higher-toxicity to lower-toxicity flavors (as
identified by Project 1). Endpoints include clinically relevant biomarkers of inflammation and oxidative stress,
changes in respiratory function, subjective respiratory symptoms and side-effects, and expression of immune
and inflammatory response genes in nasal epithelial cells. Outcomes for Regulatory Science: Assessment of
respiratory...

## Key facts

- **NIH application ID:** 9999508
- **Project number:** 5U54CA228110-03
- **Recipient organization:** ROSWELL PARK CANCER INSTITUTE CORP
- **Principal Investigator:** Maciej Lukasz Goniewicz
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $431,903
- **Award type:** 5
- **Project period:** 2018-09-14 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9999508

## Citation

> US National Institutes of Health, RePORTER application 9999508, Research Project 3: Respiratory health effects of flavors (5U54CA228110-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9999508. Licensed CC0.

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