Ongoing Lung Decline With Age Intensified Response
NCT07676435 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-07-01
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).
Conditions
- Age-Related Lung Function Decline
Interventions
- DRUG
-
Fisetin
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.
- 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.
Sponsors & Collaborators
-
Cedars-Sinai Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-06-17
- Primary Completion
- 2027-06-16
- Completion
- 2027-07-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease
NCT06714123 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Characterize the Safety, PK and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
NCT01203943 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
NCT01266135 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT02707640 ·Status: COMPLETED ·Phase: PHASE2
-
Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study
NCT00864786 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT05743075 ·Status: COMPLETED ·Phase: PHASE3
-
Dose Escalating Study of CCI15106 Inhalation Capsules in Healthy Subjects and Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT03243760 ·Status: TERMINATED ·Phase: PHASE1
-
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough - China Extension
NCT07650084 ·Status: RECRUITING ·Phase: PHASE3
-
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
NCT06329401 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
NCT00783406 ·Status: COMPLETED ·Phase: PHASE2
-
Repeat Dose Study in Male Healthy Volunteer Smokers
NCT00615576 ·Status: COMPLETED ·Phase: PHASE1
-
Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in COPD Cachexia
NCT02442908 ·Status: COMPLETED ·Phase: NA
-
Phase II Clinical Study of BC006 in Patients With Idiopathic Pulmonary Fibrosis
NCT07447102 ·Status: RECRUITING ·Phase: PHASE2
-
A Safety, Tolerability, and Pharmacokinetic Study of NIP292 in Healthy Normal Subjects
NCT04720443 ·Status: COMPLETED ·Phase: PHASE1
-
Enhancement of in-Vitro GC Function in Patients With COPD
NCT00241631 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug
NCT03235726 ·Status: COMPLETED ·Phase: PHASE1
-
Autologous Bronchial Basal Cells Transplantation for Treatment of CRD Including COPD, BE and PF
NCT03153800 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00758706 ·Status: COMPLETED ·Phase: PHASE2
-
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00758459 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
NCT04419506 ·Status: COMPLETED ·Phase: PHASE2
-
An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease
NCT02366637 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
NCT01566604 ·Status: COMPLETED ·Phase: PHASE3
-
Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT01054170 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis
NCT07503587 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Dose-Escalation Study of Artesunate Patients With IPF
NCT05988463 ·Status: RECRUITING ·Phase: PHASE1