Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT07116460
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT07116460
Study Brief:
Protocol Section:
NCT07116460