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

NCT07116460 | Not Yet Recruiting FDA Device

• 2 other identifiers: AAAV8505NYHHU009624
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Attack; Lung Function; Airway Inflammation

Keywords

asthma; air cleaner; particulate matter; pm2.5; lung function; airway inflammation; children

Outcome Measures

Primary Outcomes (4)

• Fractional Exhaled Nitric Oxide (FeNO)

  A portable fractional exhaled nitric oxide (FeNO) monitor will used to measure exhaled NO, a biomarker of airway inflammation. FeNO will be measured at four timepoints with respect to the time the air cleaner is turned on.

  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

  Easy to use, pocket-size spirometers (MIR) will be delivered to the homes along with the initial delivery of equipment. Subjects will be thoroughly trained on how to perform a pulmonary function test (PFT). These spirometers connect via Bluetooth to an application previously installed on the subject's cell phone. PFT data will be downloaded onto Columbia University computers from the app and the results will be scored and validated by trained personnel under the supervision of a spirometry expert. FEV1/FVC measures the proportion of vital capacity expired in the first second of forced expiration to the full forced vital capacity (how much air can be exhaled). FEV1/FVC will be measured at 15 timepoints with respect to the time the air cleaner is turned on.

  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

  The number of attacks of wheezing in the past 4 weeks will be reported.

  Once per month for up to 12 months after the air cleaner is turned on

• Number of Emergency Department (ED) Visits

  Number of ED visits in the past year.

  12 months after the air cleaner is turned on

Study Arms (1)

Air Cleaner Intervention

EXPERIMENTAL

Participants in this single arm of the study will be enrolled for a one-year trial of a HEPA air cleaner. Subjects will serve as their own controls.

Device: Austin Air Cleaner

Interventions

Austin Air Cleaner DEVICE

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.

Air Cleaner Intervention

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• Little Sisters of the Assumption Family Health Service: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Matthew S Perzanowski, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew S Perzanowski, PhD

CONTACT

(212) 305-3465; mp2217@cumc.columbia.edu

Luis M Acosta, MD

CONTACT

(212) 305-6925; la181@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Environmental Health Sciences

Model Details: Participants will be enrolled for a one-year trial of a HEPA air cleaner. All subjects will receive the air cleaner. Subjects will serve as their own controls. Given the existing evidence that air cleaners can reduce asthma morbidity, a sham or control group does not seem to be necessary nor ethically sound for this intervention.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 11, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the end of the funding period.
• Access Criteria: All dataset(s) that can be shared will be deposited in the Data Archive for Demography and Population Sciences (DSDR). This repository is supported by the Inter-university Consortium for Political and Social Research (ICPSR).

Locations

US (1)