Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-04 @ 7:24 PM
Study NCT ID:
NCT07453667
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Humidity Asthma Interventions for Low Socioeconomic Status Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pediatric asthma control', 'timeFrame': 'Baseline and 3 months', 'description': '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.'}, {'measure': 'Change in asthma-related quality of life', 'timeFrame': 'Baseline and 3 months', 'description': "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."}, {'measure': 'Hospitalizations', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in frequency of hospitalizations/emergency room utilization'}, {'measure': 'Missing work/school', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in the number of self-reported missed work or school days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'environmental health', 'indoor air quality', 'endotoxin', 'mold', 'humidity'], 'conditions': ['Pediatric Asthma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of asthma by one child (\\< 18 years of age) living within the home\n* Parent/guardian able to complete informed consent\n* Residence within the City of Cleveland or immediate suburbs (e.g., East Cleveland, Garfield Heights, Warrensville Heights, Parma, Brook Park, Brooklyn/Old Brooklyn)\n\nExclusion Criteria:\n\n* \\> 18 years of age\n* Rental property with landlord unwilling or unable to give consent for remediation'}, 'identificationModule': {'nctId': 'NCT07453667', 'acronym': 'INHALE', 'briefTitle': 'Humidity Asthma Interventions for Low Socioeconomic Status Children', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Novel Strategies to Improve Housing Quality and Respiratory Health for Low Socioeconomic Status Children With Asthma', 'orgStudyIdInfo': {'id': 'STUDY20231336'}, 'secondaryIdInfos': [{'id': 'FR-6700-N-15', 'type': 'OTHER_GRANT', 'domain': 'Housing and Urban Development'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No humidity interventions implemented'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Received the humidity interventions', 'interventionNames': ['Other: Healthy home intervention']}], 'interventions': [{'name': 'Healthy home intervention', 'type': 'OTHER', 'description': 'Healthy home interventions including low cost humidity interventions.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Bridget Hegarty, PhD', 'role': 'CONTACT', 'email': 'beh53@case.edu', 'phone': '216-368-2950'}], 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Maeve MacMurdo, MBChB', 'role': 'CONTACT', 'email': 'macmurm@ccf.org', 'phone': '216-445-0746'}, {'name': 'Maggie Urban-Waala, MPH', 'role': 'CONTACT', 'email': 'urbanm6@ccf.org', 'phone': '216-938-2413'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Bridget Hegarty, PhD', 'role': 'CONTACT', 'email': 'beh53@case.edu', 'phone': '216-368-2950'}], 'overallOfficials': [{'name': 'Bridget Hegarty, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared in order to preserve participant privacy given the small sample size and potentially identifiable information collected.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}