- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Samuel Cohen, MD
- Número de telefone: 310-423-1725
- E-mail: samuel.cohen@csmc.edu
Estude backup de contato
- Nome: Yunhee Choi-Kuaea
- E-mail: yunhee.choi-kuaea@cshs.org
Locais de estudo
-
-
California
-
Los Angeles, California, Estados Unidos, 90048
- Recrutamento
- Cedars-Sinai Medical Center
-
Contato:
- Yunhee Choi-Kuaea
- E-mail: yunhee.choi-kuaea@cshs.org
-
Investigador principal:
- Samuel Cohen, MD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
Comparador de Placebo: Placebo
Participants receive matching placebo capsules administered on the same schedule as the fisetin arm (Days 1-2 and Days 8-9).
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Forced Vital Capacity (FVC)
Prazo: Baseline and Day 14
|
Forced vital capacity measured by spirometry to assess lung function following treatment with fisetin versus placebo.
|
Baseline and Day 14
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Prazo: Baseline and Day 14
|
Forced expiratory volume in one second measured by spirometry following treatment with fisetin versus placebo.
|
Baseline and Day 14
|
|
FEV1/FVC Ratio
Prazo: Baseline and Day 14
|
Ratio of FEV1 to FVC measured by spirometry following treatment with fisetin versus placebo.
|
Baseline and Day 14
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
6-Minute Walk Distance (6MWD)
Prazo: Baseline and Day 14
|
Change in distance walked during a standardized 6-minute walk test, with pulse oximetry monitoring before and after the test.
|
Baseline and Day 14
|
|
Peak Oxygen Uptake (VO₂)
Prazo: Baseline and Day 14
|
Change in peak oxygen uptake measured during cardiopulmonary exercise testing (CPET) as an assessment of exercise capacity and cardiopulmonary fitness.
|
Baseline and Day 14
|
|
Biomarkers of Cellular Senescence
Prazo: Baseline and Day 14
|
Change in circulating biomarkers associated with cellular senescence measured from blood samples collected before and after treatment.
|
Baseline and Day 14
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00003866
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .