American Lung Association (ALA) Lung Health Cohort

Официальное название

The American Lung Association (ALA) Lung Health Cohort

Обзор

The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages.

Подробное описание

The scientific goal of the study is to establish the relationship between a variety of factors (lifetime environmental exposures, fitness and physical activity, biomarkers, nasal respiratory epithelial transcriptome) and ideal versus impaired peak lung health (reserve and markers of susceptibility in investigators' model) in young adulthood. In addition to the initial baseline assessment, remote contacts (e.g., via text message, email, mail, or phone) at regular intervals will allow for both the retention of the participants as well as the collection of additional short-term follow-up information, i.e., within 4.5 years of enrollment. If additional funding becomes available, investigators will extend the study for an additional period of time to study factors related to long-term changes in lung health over time, i.e., at 5 years and beyond. Recruitment of participants will be conducted by the participating study sites along with national and regional efforts from the American Lung Association. Recruitment efforts will be supported by the study web site www.lung.org/lung-study

Первичные конечные точки

• Pre-bronchodilator measurement of Forced Expiratory Volume in one second (FEV1) [Срок оценки: Baseline]
• Pre-bronchodilator measurements of Forced Vital Capacity (FVC) [Срок оценки: Baseline]

Критерии участия

Критерии включения

1- Age 25-35 years at the time of the baseline examination 2- Able to read and understand English or Spanish 3 -Has a social security number 4- Resident (citizen or non-citizen) of the United States (US) for at least 12 months prior to examination. Note: Individuals who are residents of the US who have temporarily spent time living outside of the US during the last 12 months (e.g., student exchange program, military posting) are eligible for participation.

5- Willing to provide contact information for at least 2 proxies who are likely to know the whereabouts and vital status of the participant

Критерии исключения

• Severe asthma, which is defined as any of the following:

• Current (i.e. at the time of the visit) GINA Step 4 or higher therapy (medium dose ICS/LABA or high dose ICS or add-on LAMA; Medium dose = >250 fluticasone, propionate =100 fluticasone furoate, >200 beclomethasone, >400 budesonide, >220 mometasone). We will accept low-dose ICS/LABA or medium dose ICS.

OR

• 3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months OR
• One asthma hospitalization in the past 12 months
• History of any chronic lung disease other than asthma including but not limited to COPD, cystic fibrosis, pulmonary fibrosis, pulmonary hypertension
• Current pregnancy
• History of cancer other than non-melanoma skin cancer
• Diagnosed cardiovascular diseases (i.e., congenital heart disease, coronary heart disease)
• Inability to comply with study procedures, including

• Inability or unwillingness to provide informed consent
• Inability to perform study measurements
• Inability to be contacted by phone (via calls and/or text messaging) or email
• Any condition in the opinion of the physician that puts the participant at risk by participating in the study (e.g., serious respiratory illness requiring antibiotics or steroids or severe fever at the time of the study visit).
• Institutionalization

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 37 центров

• University Of Alabama — Birmingham
• University of Arizona-Tuscon — Tucson
• University of California, Los Angeles — Los Angeles
• University of California, San Francisco — San Francisco
• University of Colorado — Aurora
• National Jewish Health — Denver
• Nemours Children's Jacksonville — Jacksonville
• University of Florida, Jacksonville — Jacksonville
• … и ещё 29 центров

Идентификаторы

NCT: NCT04543461 · IRB00236497 · U01HL146408

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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