Health Effects

Respiratory Health Effects of Flavors

Maciej Goniewicz, Ph.D., Pham.Principal Investigator(s):  Maciej L. Goniewicz, Roswell Park Comprehensive Cancer Center

More information about the respiratory health hazards of the flavorings used in tobacco products would Doctor examining a lung radiographybe useful. The goal of this project is to characterize the respiratory health effects — including inflammation, biomarkers of exposure, and clinical markers with relevance to disease endpoints — attributable to the use of flavored tobacco products. Two studies will evaluate daily ENDS users as they switch among various flavors.

Study aims:

(1) to assess changes in respiratory symptoms and biomarker levels in ENDS users during spontaneous switching between flavors (Study 1);

(2) to evaluate respiratory symptoms in ENDS users switching from flavors of potentially high toxicity to flavors of potentially low toxicity (Study 2); and

Microscope examination of cells in clinic(3) to characterize ENDS users’ preferences, selection, patterns of use and switching between various flavors (Studies 1&2). In Study 1, researchers will establish a cohort of 176 ENDS users (ages 18-54) to assess changes in respiratory symptoms during spontaneous switching among flavors over one year. In Study 2, researchers will conduct a randomized, parallel-group open-label trial to evaluate respiratory symptoms in 216 ENDS users (ages 18-54) switching from higher-toxicity to lower-toxicity flavors (as identified by Project 1). Endpoints will 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. Results may inform future regulatory activities related to flavors.