A Phase 2 interventional study of Fisetin and Placebo in Age-Related Lung Function Decline, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Cedars-Sinai Medical Center · Phase 2, Interventional, and Treatment
This Phase II, randomized, double-blind, placebo-controlled pilot study will evaluate the effects of fisetin, a senolytic flavonoid compound, on lung function and biomarkers of cellular senescence in older adults aged 60 years and older. Participants will include individuals with a history of at least 10 pack-years of smoking as well as age-matched never-smokers. Forty participants will be randomized to receive either fisetin or placebo using a short-course "hit-and-run" dosing strategy (approximately 20 mg/kg/day orally for 2 consecutive days on Days 1-2 and Days 8-9).
This Phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the effects of fisetin, a naturally occurring flavonoid with senolytic properties, on pulmonary health in older adults. Aging and cigarette smoke exposure have both been associated with cellular senescence, a biological process characterized by the accumulation of dysfunctional cells that may contribute to progressive decline in organ function. The study investigates whether intermittent administration of fisetin can favorably influence lung physiology and biological markers associated with aging.
Participants will be randomized to receive either fisetin or placebo and will undergo a short-course treatment regimen using a "hit-and-run" approach intended to transiently target senescent cells. The study population includes older adults with and without a history of cigarette smoking to allow assessment across groups with differing risk for accelerated pulmonary aging.
Study procedures include clinical evaluations, pulmonary function testing, exercise-based assessments, electrocardiography, laboratory testing, and collection of blood and urine samples for analysis of biomarkers related to cellular senescence and aging. Participants will be followed over a two-week study period, during which safety, tolerability, and protocol feasibility will be assessed. The results of this pilot study are intended to inform the design of future trials evaluating senolytic therapies as potential interventions for age-related declines in lung function and health.
268 studies on the registry are indexed under Smoking; 136 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 211 interventional studies indexed under Smoking.
Browse Smoking studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
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Exclusion Criteria:
Participants receive oral fisetin at approximately 20 mg/kg/day for 2 consecutive days on Days 1-2 and again on Days 8-9 using a senolytic "hit-and-run" dosing strategy.
Drug: Fisetin
Participants receive matching placebo capsules administered on the same schedule as the fisetin arm (Days 1-2 and Days 8-9).
Drug: Placebo
Participants randomized to the experimental arm will receive oral fisetin capsules administered at a target dose of approximately 20 mg/kg/day for 2 consecutive days on Days 1-2 and again on Days 8-9. Fisetin will be supplied as 100 mg capsules and dosed according to body weight using a senolytic "hit-and-run" treatment approach.
Participants randomized to the control arm will receive matching placebo capsules administered orally on the same schedule as the fisetin arm (Days 1-2 and Days 8-9). Placebo will be used to maintain blinding and permit comparison of efficacy and safety outcomes between treatment groups.
Forced Vital Capacity (FVC)
Forced vital capacity measured by spirometry to assess lung function following treatment with fisetin versus placebo.
Time frame: Baseline and Day 14
Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in one second measured by spirometry following treatment with fisetin versus placebo.
Time frame: Baseline and Day 14
FEV1/FVC Ratio
Ratio of FEV1 to FVC measured by spirometry following treatment with fisetin versus placebo.
Time frame: Baseline and Day 14
6-Minute Walk Distance (6MWD)
Change in distance walked during a standardized 6-minute walk test, with pulse oximetry monitoring before and after the test.
Time frame: Baseline and Day 14
Peak Oxygen Uptake (VO₂)
Change in peak oxygen uptake measured during cardiopulmonary exercise testing (CPET) as an assessment of exercise capacity and cardiopulmonary fitness.
Time frame: Baseline and Day 14
Biomarkers of Cellular Senescence
Change in circulating biomarkers associated with cellular senescence measured from blood samples collected before and after treatment.
Time frame: Baseline and Day 14
Plan to share: No — Individual participant data collected during this study will not be made publicly available. De-identified aggregate study results may be reported in publications and presentations. Requests for additional data may be considered by the Principal Investigator on a case-by-case basis and in accordance with applicable institutional policies, participant consent, privacy regulations, and IRB requirements.
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