Age-Related Lung Function DeclinePhase 2OLD AIRNCT07676435
Ongoing Lung Decline With Age Intensified Response
A Phase 2 study testing Fisetin in people with Age-Related Lung Function Decline, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Lung Function Decline
- What is being tested?
- Fisetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2026to 15 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Active malignancy, except non-melanoma skin cancer.
- Clinically significant hepatic, renal, cardiovascular, endocrine, immunologic, metabolic, or other uncontrolled medical conditions that, in the opinion of the investigator, would interfere with study participation or interpretation of results.
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- Clinically significant laboratory abnormalities, including severe anemia, leukopenia, thrombocytopenia, uncontrolled diabetes, advanced kidney disease, significant liver dysfunction, or evidence of systemic inflammation.
- Human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C infection, or invasive fungal infection.
- History of diverticulitis or diverticulosis with gastrointestinal bleeding.
- Current use of systemic corticosteroids.
- Current use of warfarin.
- Current use of medications with significant interaction potential with fisetin, including selected CYP450 or transporter substrates, inhibitors, or inducers, unless such medications can be safely withheld according to protocol requirements.
- Recent medication, supplement, or lifestyle changes that may affect study outcomes, in the opinion of the investigator.
- Inability to perform required study procedures, including pulmonary function testing, exercise testing, or other protocol assessments.
- Unwillingness or inability to provide informed consent.
- Pregnancy or breastfeeding.
- Any other condition that, in the opinion of the investigator, would make participation unsafe or compromise study integrity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Sandra Gomez, sandra.gomez@cshs.org
Tamara Evans, tamara.evans@cshs.org
About this study
Official title: A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE ONGOING LUNG DECLINE WITH AGE INTENSIFIED RESPONSE (OLD AIR)
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).
Read the detailed 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.
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.
- Conditions
- Age-Related Lung Function Decline
- Being tested
- Fisetin, Placebo
- Keywords
- Aging, Cellular Senescence, Healthy Aging, Smoking-Related Lung Function Decline, Pulmonary Function, Smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FisetinDrug
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Fisetin | Experimental | 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. Receives: Drug: Fisetin |
| Placebo | Placebo comparator | Participants receive matching placebo capsules administered on the same schedule as the fisetin arm (Days 1-2 and Days 8-9). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
Forced vital capacity measured by spirometry to assess lung function following treatment with fisetin versus placebo.
Measured: 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.
Measured: Baseline and Day 14
FEV1/FVC Ratio
Ratio of FEV1 to FVC measured by spirometry following treatment with fisetin versus placebo.
Measured: Baseline and Day 14
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start17 Jun 2026
- Primary completion16 Jun 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Lung Function DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Cohen, MD, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676435
- Sponsor's protocol ID
- STUDY00003866
- Acronym
- OLD AIR
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE ONGOING LUNG DECLINE WITH AGE INTENSIFIED RESPONSE (OLD AIR)
- ClinicalTrials.gov ID
- NCT07676435
- Acronym / sponsor ID
- OLD AIR / STUDY00003866
- Conditions
- Age-Related Lung Function Decline
- Keywords
- Aging, Cellular Senescence, Healthy Aging, Smoking-Related Lung Function Decline, Pulmonary Function, Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 16 Jun 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fisetin | Experimental | Drug: FisetinParticipants 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 | Placebo comparator | Drug: PlaceboParticipants receive matching placebo capsules administered on the same schedule as the fisetin arm (Days 1-2 and Days 8-9). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (17 listed)
- 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.
- Active malignancy, except non-melanoma skin cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FisetinParticipants 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 | Fisetin |
| PlaceboParticipants 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. | Drug | Placebo |
Primary outcome
Forced Vital Capacity (FVC)
Time frame: Baseline and Day 14
Forced vital capacity measured by spirometry to assess lung function following treatment with fisetin versus placebo.
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and Day 14
Forced expiratory volume in one second measured by spirometry following treatment with fisetin versus placebo.
FEV1/FVC Ratio
Time frame: Baseline and Day 14
Ratio of FEV1 to FVC measured by spirometry following treatment with fisetin versus placebo.
3 secondary outcomes
6-Minute Walk Distance (6MWD)
Time frame: Baseline and Day 14
Peak Oxygen Uptake (VO₂)
Time frame: Baseline and Day 14
Biomarkers of Cellular Senescence
Time frame: Baseline and Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fisetin in people with Age-Related Lung Function Decline, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Cohen, MD (424-315-0685, samuel.cohen@csmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: Baseline and Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.