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Completed

NCT Number: NCT06098287

Residential Ventilation Systems and Filtration for Asthma Control in Adults

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Residential mechanical ventilation system (Exhaust)

Device

Exhaust-only ventilation system

Residential mechanical ventilation system (CFIS) and air filtration upgrades

Device

Central-fan-integrated-supply ventilation system and air filtration upgrades (MERV 10)

Residential mechanical ventilation system (ERV) and air filtration upgrades

Device

Balanced energy recovery ventilation system and air filtration upgrades (MERV 10)

Primary outcomes

  1. Asthma Control

    Time frame: Each month throughout the study completion, an average of 2 years (24 months)

    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")

Secondary outcomes

  1. Health-Related Quality of Life

    Time frame: Baseline (July 2017) and end-line (March 2020, end of study completion)

    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.

  2. Stress

    Time frame: Baseline (July 2017) and end-line (March 2020, end of study completion)

    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.

  3. Asthma medications

    Time frame: Baseline (July 2017) and end-line (March 2020, end of study completion)

    Asthma medications via survey

  4. Comorbidities

    Time frame: Baseline (July 2017) and end-line (March 2020, end of study completion)

    Comorbidities via survey

Sponsors and collaborators

Lead sponsor

Illinois Institute of Technology

Other

Collaborators

  • Elevate

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 24, 2023
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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