Residential Ventilation Systems and Filtration for Asthma Control in Adults

Cost-effective Approaches to Upgrading Residential Mechanical Ventilation Systems to Control Indoor Pollutants of Both Indoor and Outdoor Origin and Improve Asthma-related Health Outcomes

The goal of this study was to investigate the effectiveness of three common approaches to upgrading residential mechanical ventilation systems in existing homes for improving asthma-related health outcomes, reducing indoor pollutants of both indoor and outdoor origin, and maintaining adequate environmental conditions and ventilation rates in a cohort of adult asthmatics in existing homes in Chicago, IL.

Study Overview

• Status: Completed
• Conditions: Asthma; Pollution; Exposure
• Intervention / Treatment: Device: Residential mechanical ventilation system (Exhaust); Device: Residential mechanical ventilation system (CFIS) and air filtration upgrades; Device: Residential mechanical ventilation system (ERV) and air filtration upgrades

Detailed Description

The Breathe Easy Study utilized a quasi-randomized, within-subjects, parallel-group, pre-post intervention study design with four weeklong periods of indoor air quality (IAQ) and indoor environmental data collection for approximately one year before the installation of mechanical ventilation systems, followed by four weeklong periods of IAQ and indoor environmental data collection for approximately one year after the installation of mechanical ventilation systems, conducted from July 2017 through March 2020 in Chicago, IL. With the nature of a healthy home intervention study by installing residential mechanical ventilation systems within the timeframe, each participant received interventions in the middle of the study period, including continuous exhaust-only systems; intermittent powered central-fan-integrated-supply (CFIS) systems; or continuous balanced systems with an energy recovery ventilator. Thus, each participant served as their own control and there was no formal control group that did not receive intervention nor did they receive a sham/placebo intervention. Primary health outcome, asthma control, was assessed by using the Asthma Control Test (ACT) every month, and quality of life, stress, and other asthma-related health outcomes were assessed via the baseline and end-line surveys.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Illinois Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 18 - 90+ years.
• English speaking and writing.
• Able to provide consent.
• Chicago resident.
• Households with at least one occupant with asthma
• Non-smoking houses
• Participant-owned houses
• Participant's agreement to surveys and IAQ monitoring over 2 years

Exclusion Criteria:

• Houses outside Chicago, IL USA
• Houses with significant health and safety issues

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention (Exhaust-only ventilation); A study group with a continuous exhaust-only ventilation system	Device: Residential mechanical ventilation system (Exhaust); Exhaust-only ventilation system
Active Comparator: Intervention (Central-fan-integrated-supply ventilation); A study group with an intermittent central-fan-integrated-supply ventilation system and air filtration upgrades	Device: Residential mechanical ventilation system (CFIS) and air filtration upgrades; Central-fan-integrated-supply ventilation system and air filtration upgrades (MERV 10)
Active Comparator: Intervention (Balanced energy recovery ventilation); A study group with a continuous balanced energy recovery ventilation system and air filtration upgrades	Device: Residential mechanical ventilation system (ERV) and air filtration upgrades; Balanced energy recovery ventilation system and air filtration upgrades (MERV 10)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control	Asthma Control Test (ACT) is a 5-item clinically validated survey, which is designed to measure the multi-dimensional nature of asthma control, including asthma symptoms, utilization of rescue medications, and the impact of asthma on daily functioning. The ACT score ranges from 5 ("poor control of asthma") to 25 ("complete control of asthma")	Each month throughout the study completion, an average of 2 years (24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality of Life	12-Item Short Form Survey (SF-12) measures eight concepts commonly represented in widely used surveys: general health, physical functioning, bodily pain, vitality (energy/fatigue), social functioning, role limitations due to physical and emotional problems, and mental health (psychological distress and psychological well-being). Both the SF-12 physical (PCS) and mental (MCS) component summary scales use norm-based scoring, 0-100, with higher scores indicating better physical and mental health functioning.	Baseline (July 2017) and end-line (March 2020, end of study completion)
Stress	Perceived Stress Scale (PSS) is a 10-item psychological assessment to understand how unpredictable, uncontrollable, and overloaded participants find their lives. The PSS score ranges from 0 to 40 with higher scores indicating higher perceived stress, and scores ranging from 0 to 13, from 14 to 26, and from 27 to 40 are considered low, moderate, and high perceived stress, respectively.	Baseline (July 2017) and end-line (March 2020, end of study completion)
Asthma medications	Asthma medications via survey	Baseline (July 2017) and end-line (March 2020, end of study completion)
Comorbidities	Comorbidities via survey	Baseline (July 2017) and end-line (March 2020, end of study completion)

Collaborators and Investigators

• Sponsor: Illinois Institute of Technology
• Collaborators: Elevate

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: October 14, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Air filtration; Adult asthma; Home intervention; Indoor air pollution exposures
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: IIT IRB2019-001; ILHHU0031-16 (Other Grant/Funding Number: U.S. Department of Housing and Urban Development); P-0136 (Other Grant/Funding Number: ComEd)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No