NCT06098287

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

3.9 years

First QC Date

October 14, 2023

Last Update Submit

October 19, 2023

Conditions

AsthmaPollution; Exposure

Keywords

Adult asthmaHome interventionMechanical ventilationAir filtrationIndoor air pollution exposures

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Health-Related Quality of Life

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

  • Stress

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

  • Asthma medications

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

  • Comorbidities

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

Study Arms (3)

Intervention (Exhaust-only ventilation)

ACTIVE COMPARATOR

A study group with a continuous exhaust-only ventilation system

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

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

Device: Residential mechanical ventilation system (ERV) and air filtration upgrades

Interventions

Residential mechanical ventilation system (Exhaust)DEVICE

Exhaust-only ventilation system

Intervention (Exhaust-only ventilation)
Residential mechanical ventilation system (CFIS) and air filtration upgradesDEVICE

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

Intervention (Central-fan-integrated-supply ventilation)
Residential mechanical ventilation system (ERV) and air filtration upgradesDEVICE

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

Intervention (Balanced energy recovery ventilation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Expiratory Reserve Volume

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Functional Residual CapacityTotal Lung CapacityLung Volume MeasurementsRespiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisVital CapacityRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A quasi-randomized, within-subjects, parallel-group, pre-post intervention study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Department Chair

Study Record Dates

First Submitted

October 14, 2023

First Posted

October 24, 2023

Study Start

January 1, 2017

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)