Ongoing Lung Decline With Age Intensified Response

Conditions

• Age-Related Lung Function Decline

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Fisetin — DRUG
  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.
• Placebo — DRUG
  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.

Study Details

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).

Key Dates

Start date

Jun 17, 2026

Status verified

Jun 2026

Primary completion

Jun 16, 2027

Completion

Jul 15, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Fisetin
  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.
• Placebo Comparator: Placebo
  Participants receive matching placebo capsules administered on the same schedule as the fisetin arm (Days 1-2 and Days 8-9).

Primary Outcome Measure

Forced Vital Capacity (FVC) [ Time Frame: Baseline and Day 14 ]

Central Contacts

• Samuel Cohen, MD
  310-423-1725
  [email protected]
• Yunhee Choi-Kuaea
  [email protected]

Locations (1)

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