Ongoing Lung Decline With Age Intensified Response
ConditionAge-Related Lung Function Decline
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorCedars-Sinai Medical Center
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
Electrocardiogram (ECG) abnormalities, including prolonged QTc.
Use of fisetin, other flavonoid supplements, or known senolytic compounds within 6 months prior to screening.
Resting systolic blood pressure >160 mmHg or diastolic blood pressure >110 mmHg.
Known allergy or hypersensitivity to fisetin or any component of the study product.
Trial design
Design model
Parallel
Treatments tested in this trial
Fisetin
DrugParticipants 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.
Placebo
DrugParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: FisetinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 142
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 143
FEV1/FVC Ratio
Ratio of FEV1 to FVC measured by spirometry following treatment with fisetin versus placebo.
Time frame
Baseline and Day 14Secondary outcomes
1
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 142
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 143
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 14Sponsors and contacts
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Source ClinicalTrials.gov