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- Essai clinique NCT07676435
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)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Samuel Cohen, MD
- Numéro de téléphone: 310-423-1725
- E-mail: samuel.cohen@csmc.edu
Sauvegarde des contacts de l'étude
- Nom: Yunhee Choi-Kuaea
- E-mail: yunhee.choi-kuaea@cshs.org
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90048
- Recrutement
- Cedars-Sinai Medical Center
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Contact:
- Yunhee Choi-Kuaea
- E-mail: yunhee.choi-kuaea@cshs.org
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Chercheur principal:
- Samuel Cohen, MD
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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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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Comparateur placebo: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Forced Vital Capacity (FVC)
Délai: Baseline and Day 14
|
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)
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
6-Minute Walk Distance (6MWD)
Délai: 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)
Délai: Baseline and Day 14
|
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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00003866
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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