A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE ONGOING LUNG DECLINE WITH AGE INTENSIFIED RESPONSE (OLD AIR)
Cedars-Sinai Medical Center
Summary
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).
Description
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. Partic…
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Adults aged 60 years and older who are physically capable of participating in study procedures; * Willing to be randomized to fisetin or placebo; weight stable within the previous 2 months (\<5-pound change); * No blood donation within 2 months before screening; absence of unstable chronic disease; * Willing to maintain baseline activity level throughout the study; * Body mass index \<30 kg/m²; * Either a history of at least 10 pack-years of cigarette smoking or never-smoking status. Exclusion Criteria: * Electrocardiogram (ECG) abnormalities, including prolonged QTc.…
Interventions
- DrugFisetin
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.
- DrugPlacebo
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.
Location
- Cedars-Sinai Medical CenterLos Angeles, California