Pediatric AsthmaINHALENCT07453667
Humidity Asthma Interventions for Low Socioeconomic Status Children
A study testing Healthy home intervention in people with Pediatric Asthma, run by Case Western Reserve University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Asthma
- What is being tested?
- Healthy home intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- > 18 years of age
- Rental property with landlord unwilling or unable to give consent for remediation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Bridget Hegarty, PhD, 216-368-2950, beh53@case.edu
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Maeve MacMurdo, MBChB, 216-445-0746, macmurm@ccf.org
Maggie Urban-Waala, MPH, 216-938-2413, urbanm6@ccf.org
About this study
Official title: 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.
- Conditions
- Pediatric Asthma
- Being tested
- Healthy home intervention
- Keywords
- asthma, environmental health, indoor air quality, endotoxin, mold, humidity
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy home interventionOther
Healthy home interventions including low cost humidity interventions.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No humidity interventions implemented |
| Intervention | Experimental | Received the humidity interventions Receives: Other: Healthy home intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 3 months
Hospitalizations
Change in frequency of hospitalizations/emergency room utilization
Measured: Baseline and 3 months
Missing work/school
Change in the number of self-reported missed work or school days
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start2 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Bridget Hegarty, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453667
- Sponsor's protocol ID
- STUDY20231336
- Other IDs
- FR-6700-N-15
- Acronym
- INHALE
- Status last verified
- Jun 2026
- First submitted
- 2 Mar 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared in order to preserve participant privacy given the small sample size and potentially identifiable information collected.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Strategies to Improve Housing Quality and Respiratory Health for Low Socioeconomic Status Children With Asthma
- ClinicalTrials.gov ID
- NCT07453667
- Acronym / sponsor ID
- INHALE / STUDY20231336
- Conditions
- Pediatric Asthma
- Keywords
- asthma, environmental health, indoor air quality, endotoxin, mold, humidity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 2 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Mar 2026 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No humidity interventions implemented |
| Intervention | Experimental | Other: Healthy home interventionReceived the humidity interventions |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- > 18 years of age
- Rental property with landlord unwilling or unable to give consent for remediation
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 |
|---|---|---|
| Healthy home interventionHealthy home interventions including low cost humidity interventions. | Other | Intervention |
Primary outcome
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.
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.
Hospitalizations
Time frame: Baseline and 3 months
Change in frequency of hospitalizations/emergency room utilization
Missing work/school
Time frame: Baseline and 3 months
Change in the number of self-reported missed work or school days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. IPD will not be shared in order to preserve participant privacy given the small sample size and potentially identifiable information collected.
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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.
Bridget Hegarty, PhD principal investigator
Case Western Reserve University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy home intervention in people with Pediatric Asthma, run by Case Western Reserve University at 2 sites in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bridget Hegarty, PhD (216-368-2950, beh53@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pediatric asthma control (time frame: Baseline and 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.