An interventional study of Residential mechanical ventilation system (Exhaust) and Residential mechanical ventilation system (CFIS) and air filtration upgrades in Asthma and Pollution; Exposure, sponsored by Illinois Institute of Technology. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by Illinois Institute of Technology · Not applicable, Interventional, and Treatment
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.
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.
4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 51 is below the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Illinois Institute of Technology is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
A study group with a continuous exhaust-only ventilation system
Device: Residential mechanical ventilation system (Exhaust)
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
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
Exhaust-only ventilation system
Central-fan-integrated-supply ventilation system and air filtration upgrades (MERV 10)
Balanced energy recovery ventilation system and air filtration upgrades (MERV 10)
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")
Time frame: Each month throughout the study completion, an average of 2 years (24 months)
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.
Time frame: 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.
Time frame: Baseline (July 2017) and end-line (March 2020, end of study completion)
Asthma medications
Asthma medications via survey
Time frame: Baseline (July 2017) and end-line (March 2020, end of study completion)
Comorbidities
Comorbidities via survey
Time frame: Baseline (July 2017) and end-line (March 2020, end of study completion)
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Nov 2020, 46 months.
Of 466 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 47. This study's 46 months is above that.
Counting every sponsor, half of 502 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Illinois Institute of Technology