Residential Ventilation Systems and Filtration for Asthma Control in Adults

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06098287
• Other study ID #: IIT IRB2019-001
• Secondary ID: ILHHU0031-16P-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: October 2023
• Source: Illinois Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Pollution; Exposure

Intervention

Device:
• Residential mechanical ventilation system (Exhaust)
Exhaust-only ventilation system
• Residential mechanical ventilation system (CFIS) and air filtration upgrades
Central-fan-integrated-supply ventilation system and air filtration upgrades (MERV 10)
• Residential mechanical ventilation system (ERV) and air filtration upgrades
Balanced energy recovery ventilation system and air filtration upgrades (MERV 10)

Locations

Country	Name	City	State
United States	Illinois Institute of Technology	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Illinois Institute of Technology	Elevate

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Asthma medications	Asthma medications via survey	Baseline (July 2017) and end-line (March 2020, end of study completion)
Secondary	Comorbidities	Comorbidities via survey	Baseline (July 2017) and end-line (March 2020, end of study completion)