- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Samuel Cohen, MD
- Número de teléfono: 310-423-1725
- Correo electrónico: samuel.cohen@csmc.edu
Copia de seguridad de contactos de estudio
- Nombre: Yunhee Choi-Kuaea
- Correo electrónico: yunhee.choi-kuaea@cshs.org
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90048
- Reclutamiento
- Cedars-Sinai Medical Center
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Contacto:
- Yunhee Choi-Kuaea
- Correo electrónico: yunhee.choi-kuaea@cshs.org
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Investigador principal:
- Samuel Cohen, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Forced Vital Capacity (FVC)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Baseline and Day 14
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Ratio of FEV1 to FVC measured by spirometry following treatment with fisetin versus placebo.
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Baseline and Day 14
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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6-Minute Walk Distance (6MWD)
Periodo de tiempo: Baseline and Day 14
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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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00003866
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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