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Идёт набор NCT07116460

Cost Effective Air Filtration Intervention in Low-Income Housing to Reduce Asthma Morbidity

Без фазы С лечением Asthma Attack Lung Function Airway Inflammation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Austin Air Cleaner.
Кому может быть актуально
Состояния в реестре: Asthma Attack, Lung Function, Airway Inflammation. Базовые параметры: 7 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Cost Effective Air Filtration Intervention and Particulate Matter Monitoring in Low-Income Housing to Reduce Asthma Morbidity

Обзор

This project will investigate the effectiveness of HEPA air cleaners in reducing indoor air pollution and improving asthma morbidity in children living in East Harlem, New York City (NYC). The study will be conducted over a 2-year period. Columbia University and Little Sisters of the Assumption Family Health Service (LSAFHS) will conduct an intervention study to evaluate the efficacy of using a cost-effective high-capacity high efficiency particulate air (HEPA) filter air cleaner to reduce airborne particulate matter (PM) in the homes of children with asthma and to reduce their asthma morbidity. The study will take place in East Harlem, a low-income neighborhood with high asthma prevalence. It will build on findings from prior Housing and Urban Development Lead and Healthy Homes Technical Studies (HUD LHHTS)-funded research, the experience of LSAFHS installing air cleaners in the homes of asthmatic children, and recent findings demonstrating the effectiveness of home air cleaners in reducing asthma morbidity. The investigators hypothesize that the cost-effective single air cleaner will substantially reduce PM exposure in the homes of asthmatic children and reduce airway inflammation and asthma morbidity. This study will use cutting-edge air sampling technology to continuously quantify and characterize indoor air pollutants in the home for one year, verify and incentivize compliance, and conduct repeated exhaled nitric oxide and pulmonary function tests before and throughout the year after the intervention. This cost-effective intervention can be easily and quickly implemented in homes in low-income, urban communities and easily transferred between homes if families move.

Подробное описание

The investigators propose an intervention study to evaluate if using a cost-effective high-capacity air filter will reduce air pollutants in the homes of asthmatic children and reduce their asthma symptoms. The study will take place in New York City, including East Harlem, a low-income, primarily Latino neighborhood with high asthma prevalence. The investigators hypothesize that a cost-effective single air cleaner placed in the homes of asthmatic children will substantially reduce air pollutants exposure and reduce airway inflammation and asthma symptoms. During the intervention, the study team will continuously monitor indoor air pollution by measuring particulate matter (tiny particles suspended in the air) for one year, verify and incentivize compliance, and conduct two types of breathing tests on the asthmatic child throughout the intervention: 1. One test measures exhaled nitric oxide (a gas collected by blowing air in a portable device, the levels of this gas are higher when there is inflammation in the airways), and 2. The second breathing test is a pulmonary function test (to measure lung capacity and diameter of the airways). The study team will also collect asthma symptom information through questionnaires. If successful, this study will provide evidence for a cost-effective intervention implemented without structural housing changes that can be easily and quickly implemented in homes in low-income urban communities. This study design will utilize a set of air monitors that will allow for high resolution quantification and characterization of particulate matter in the home before the intervention and one-year after placement of the air filter, which will allow researchers to better understand the impact of the filter on home air quality throughout the year. The study team will test the hypothesis that the single filter will substantially reduce particulate matter in the homes of asthmatic children and reduce airway inflammation and asthma morbidity in the child.

Вмешательства

  • Устройство Austin Air Cleaner
    The Austin Air Purifier consists of 4 stages, a large particle pre-filter, medium pre-filter, a medical grade HEPA filter and a high efficiency gas arrestance carbon cloth to reduce air pollution in homes.

Первичные конечные точки

  • Fractional Exhaled Nitric Oxide (FeNO) [Срок оценки: 1 week before, immediately before, two weeks after, and one year after the air cleaner is turned on.]
  • Forced Expiratory Volume in 1 Second/ Forced Vital Capacity (FEV1/FVC) Ratio [Срок оценки: 1 week before, immediately before, two weeks after, then once a month (up to 1 year) after the air cleaner is turned on.]
  • Number of Attacks of Wheezing [Срок оценки: Once per month for up to 12 months after the air cleaner is turned on]
  • Number of Emergency Department (ED) Visits [Срок оценки: 12 months after the air cleaner is turned on]

Критерии участия

Критерии включения

  • Age 7-18 years
  • Asthma symptoms in the past 4 weeks
  • Resident in lower-income housing in NYC Northern Manhattan and South Bronx

Критерии исключения

  • Inability to successfully perform spirometry maneuver or FeNO test
  • Family planning to move in the next year

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Columbia University Irving Medical Center — New York

Идентификаторы

NCT: NCT07116460 · AAAV8505 · NYHHU009624

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗