AsthmaNCT06098287

Residential Ventilation Systems and Filtration for Asthma Control in Adults

A study testing Residential mechanical ventilation system (Exhaust), Residential mechanical ventilation system (CFIS) and air filtration upgrades and Residential mechanical ventilation system (ERV) and air filtration upgrades in people with Asthma and Pollution; Exposure, run by Illinois Institute of Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma, Pollution; Exposure
What is being tested?: Residential mechanical ventilation system (Exhaust), Residential mechanical ventilation system (CFIS) and air filtration upgrades and Residential mechanical ventilation system (ERV) and air filtration upgrades
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2017to 30 Nov 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Illinois Institute of Technology
Chicago, Illinois, 60616

Other trials in United States

About this study

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

Read the 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.

Conditions: Asthma, Pollution; Exposure
Being tested: Residential mechanical ventilation system (Exhaust), Residential mechanical ventilation system (CFIS) and air filtration upgrades, Residential mechanical ventilation system (ERV) and air filtration upgrades
Keywords: Adult asthma, Home intervention, Mechanical ventilation, Air filtration, Indoor air pollution exposures
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06098287
Study group	Role	What they receive
Intervention (Exhaust-only ventilation)	Active comparator	A study group with a continuous exhaust-only ventilation system Receives: Device: Residential mechanical ventilation system (Exhaust)
Intervention (Central-fan-integrated-supply ventilation)	Active comparator	A study group with an intermittent central-fan-integrated-supply ventilation system and air filtration upgrades Receives: Device: Residential mechanical ventilation system (CFIS) and air filtration upgrades
Intervention (Balanced energy recovery ventilation)	Active comparator	A study group with a continuous balanced energy recovery ventilation system and air filtration upgrades Receives: Device: Residential mechanical ventilation system (ERV) and air filtration upgrades

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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.
Measured: 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.
Measured: Baseline (July 2017) and end-line (March 2020, end of study completion)
Asthma medications
Asthma medications via survey
Measured: Baseline (July 2017) and end-line (March 2020, end of study completion)
Comorbidities
Comorbidities via survey
Measured: Baseline (July 2017) and end-line (March 2020, end of study completion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201730 Nov 2020

First posted24 Oct 2023
Study start1 Jan 2017
Primary completion30 Nov 2020
Study completion30 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A quasi-randomized, within-subjects, parallel-group, pre-post intervention study
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06098287
Sponsor's protocol ID: IIT IRB2019-001
Other IDs: ILHHU0031-16, P-0136
Status last verified: Oct 2023
First submitted: 14 Oct 2023
Last updated: 24 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06098287
Acronym / sponsor ID: IIT IRB2019-001
Conditions: Asthma, Pollution; Exposure
Keywords: Adult asthma, Home intervention, Mechanical ventilation, Air filtration, Indoor air pollution exposures
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Illinois Institute of TechnologyUniversity, hospital or other
Collaborators: Elevate
Study start: 1 Jan 2017 (actual)
Primary completion: 30 Nov 2020 (actual)
Study completion: 30 Nov 2020 (actual)
First posted: 24 Oct 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: A quasi-randomized, within-subjects, parallel-group, pre-post intervention study

Arm	Type	Receives
Intervention (Exhaust-only ventilation)	Active comparator	Device: Residential mechanical ventilation system (Exhaust)A study group with a continuous exhaust-only ventilation system
Intervention (Central-fan-integrated-supply ventilation)	Active comparator	Device: Residential mechanical ventilation system (CFIS) and air filtration upgradesA study group with an intermittent central-fan-integrated-supply ventilation system and air filtration upgrades
Intervention (Balanced energy recovery ventilation)	Active comparator	Device: Residential mechanical ventilation system (ERV) and air filtration upgradesA study group with a continuous balanced energy recovery ventilation system and air filtration upgrades

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age: 18 - 90+ years.
English speaking and writing.
Able to provide consent.
Chicago resident.
Households with at least one occupant with asthma

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Residential mechanical ventilation system (Exhaust)Exhaust-only ventilation system	Device	Intervention (Exhaust-only ventilation)
Residential mechanical ventilation system (CFIS) and air filtration upgradesCentral-fan-integrated-supply ventilation system and air filtration upgrades (MERV 10)	Device	Intervention (Central-fan-integrated-supply ventilation)
Residential mechanical ventilation system (ERV) and air filtration upgradesBalanced energy recovery ventilation system and air filtration upgrades (MERV 10)	Device	Intervention (Balanced energy recovery ventilation)

Primary outcome

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")

4 secondary outcomes

Health-Related Quality of Life
Time frame: Baseline (July 2017) and end-line (March 2020, end of study completion)
Stress
Time frame: Baseline (July 2017) and end-line (March 2020, end of study completion)
Asthma medications
Time frame: Baseline (July 2017) and end-line (March 2020, end of study completion)
Comorbidities
Time frame: Baseline (July 2017) and end-line (March 2020, end of study completion)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
Individual participant dataSharing planned: No

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma Control (time frame: Each month throughout the study completion, an average of 2 years (24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06098287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.