Residential Ventilation Systems and Filtration for Asthma Control in Adults

NCT ID: NCT06098287

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Pollution; Exposure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A quasi-randomized, within-subjects, parallel-group, pre-post intervention study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention (Exhaust-only ventilation)

A study group with a continuous exhaust-only ventilation system

Group Type ACTIVE_COMPARATOR

Residential mechanical ventilation system (Exhaust)

Intervention Type DEVICE

Exhaust-only ventilation system

Intervention (Central-fan-integrated-supply ventilation)

A study group with an intermittent central-fan-integrated-supply ventilation system and air filtration upgrades

Group Type ACTIVE_COMPARATOR

Residential mechanical ventilation system (CFIS) and air filtration upgrades

Intervention Type DEVICE

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

Intervention (Balanced energy recovery ventilation)

A study group with a continuous balanced energy recovery ventilation system and air filtration upgrades

Group Type ACTIVE_COMPARATOR

Residential mechanical ventilation system (ERV) and air filtration upgrades

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Residential mechanical ventilation system (Exhaust)

Exhaust-only ventilation system

Intervention Type DEVICE

Residential mechanical ventilation system (CFIS) and air filtration upgrades

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

Intervention Type DEVICE

Residential mechanical ventilation system (ERV) and air filtration upgrades

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Elevate

UNKNOWN

Sponsor Role collaborator

Illinois Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brent Stephens

Professor and Department Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Illinois Institute of Technology

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ILHHU0031-16

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

P-0136

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIT IRB2019-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Home Air Purification for Eosinophilic COPD
NCT04252235 ACTIVE_NOT_RECRUITING NA
Classroom Air Purifiers for Reducing School Absence
NCT07119333 ENROLLING_BY_INVITATION NA
Hospital Environmental Exposure
NCT06802367 NOT_YET_RECRUITING