Ongoing Lung Decline With Age Intensified Response (OLD AIR)
A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE ONGOING LUNG DECLINE WITH AGE INTENSIFIED RESPONSE (OLD AIR)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Samuel Cohen, MD
- 電話番号：310-423-1725
- メール：samuel.cohen@csmc.edu
研究連絡先のバックアップ
- 名前：Yunhee Choi-Kuaea
- メール：yunhee.choi-kuaea@cshs.org
研究場所
-
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California
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Los Angeles、California、アメリカ、90048
- 募集
- Cedars-Sinai Medical Center
-
コンタクト：
- Yunhee Choi-Kuaea
- メール：yunhee.choi-kuaea@cshs.org
-
主任研究者：
- Samuel Cohen, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
- 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.
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
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プラセボコンパレーター：Placebo
Participants receive matching placebo capsules administered on the same schedule as the fisetin arm (Days 1-2 and Days 8-9).
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Forced Vital Capacity (FVC)
時間枠：Baseline and Day 14
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Forced vital capacity measured by spirometry to assess lung function following treatment with fisetin versus placebo.
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Baseline and Day 14
|
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Forced Expiratory Volume in 1 Second (FEV1)
時間枠：Baseline and Day 14
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Forced expiratory volume in one second measured by spirometry following treatment with fisetin versus placebo.
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Baseline and Day 14
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FEV1/FVC Ratio
時間枠：Baseline and Day 14
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Ratio of FEV1 to FVC measured by spirometry following treatment with fisetin versus placebo.
|
Baseline and Day 14
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
6-Minute Walk Distance (6MWD)
時間枠：Baseline and Day 14
|
Change in distance walked during a standardized 6-minute walk test, with pulse oximetry monitoring before and after the test.
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Baseline and Day 14
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Peak Oxygen Uptake (VO₂)
時間枠：Baseline and Day 14
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Change in peak oxygen uptake measured during cardiopulmonary exercise testing (CPET) as an assessment of exercise capacity and cardiopulmonary fitness.
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Baseline and Day 14
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Biomarkers of Cellular Senescence
時間枠：Baseline and Day 14
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Change in circulating biomarkers associated with cellular senescence measured from blood samples collected before and after treatment.
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Baseline and Day 14
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00003866
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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