NCT07453667

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started May 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
May 2026May 2027

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 2, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

March 2, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

asthmaenvironmental healthindoor air qualityendotoxinmoldhumidity

Outcome Measures

Primary Outcomes (4)

  • Change in pediatric asthma control

    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

    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

  • Hospitalizations

    Change in frequency of hospitalizations/emergency room utilization

    Baseline and 3 months

  • Missing work/school

    Change in the number of self-reported missed work or school days

    Baseline and 3 months

Study Arms (2)

Control

NO INTERVENTION

No humidity interventions implemented

Intervention

EXPERIMENTAL

Received the humidity interventions

Other: Healthy home intervention

Interventions

Healthy home interventions including low cost humidity interventions.

Intervention

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bridget Hegarty, PhD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bridget Hegarty, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 6, 2026

Study Start

May 2, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

June 3, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations