Humidity Asthma Interventions for Low Socioeconomic Status Children (INHALE)

June 2, 2026 updated by: Case Western Reserve University

Novel Strategies to Improve Housing Quality and Respiratory Health for Low Socioeconomic Status Children With Asthma

The goal of this intervention study is to assess the effectiveness of low-cost humidity and mold reduction interventions in the home for reducing pediatric asthma. The study will have two groups, a treatment group that receives the healthy home interventions during the study and a second control group that will receive these after the study. We will compare pediatric asthma before and three months after the healthy home interventions are performed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bridget Hegarty, PhD
  • Phone Number: 216-368-2950
  • Email: beh53@case.edu

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
        • Contact:
        • Contact:
          • Maggie Urban-Waala, MPH
          • Phone Number: 216-938-2413
          • Email: urbanm6@ccf.org
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University
        • Contact:
          • Bridget Hegarty, PhD
          • Phone Number: 216-368-2950
          • Email: beh53@case.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Documented diagnosis of asthma by one child (< 18 years of age) living within the home
  • Parent/guardian able to complete informed consent
  • Residence within the City of Cleveland or immediate suburbs (e.g., East Cleveland, Garfield Heights, Warrensville Heights, Parma, Brook Park, Brooklyn/Old Brooklyn)

Exclusion Criteria:

  • > 18 years of age
  • Rental property with landlord unwilling or unable to give consent for remediation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No humidity interventions implemented
Experimental: Intervention
Received the humidity interventions
Other: Healthy home intervention
Healthy home interventions including low cost humidity interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalizations
Time Frame: Baseline and 3 months
Change in frequency of hospitalizations/emergency room utilization
Baseline and 3 months
Missing work/school
Time Frame: Baseline and 3 months
Change in the number of self-reported missed work or school days
Baseline and 3 months
Change in pediatric asthma control
Time Frame: Baseline and 3 months
Pediatric asthma control is assessed using the Asthma Control Questionnaire (ACQ), a six-item survey consisting of questions specific to asthma symptoms and bronchodilator usage. Questions are answered using a 7-point Likert scale and scored cumulatively with lower scores indicating greater asthma control. Lower scores at 3 months compared to baseline indicate overall improvement in asthma control post-intervention.
Baseline and 3 months
Change in asthma-related quality of life
Time Frame: Baseline and 3 months
Asthma-related quality of life is assessed using the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), a thirteen-item survey to assess problems that caregivers experience as a result of their child's asthma. Questions are answered using a 7-point Likert scale and scored cumulatively with higher scores indicating less impact on quality of life. Higher scores at 3 months compared to baseline indicate overall improvement in quality of life.
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Collaborators

The Cleveland Clinic

Investigators

  • Principal Investigator: Bridget Hegarty, PhD, Case Western Reserve University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20231336
  • FR-6700-N-15 (Other Grant/Funding Number: Housing and Urban Development)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared in order to preserve participant privacy given the small sample size and potentially identifiable information collected.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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