Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-01-04 @ 8:43 AM
Study NCT ID:
NCT03642418
Status:
COMPLETED
Last Update Posted:
2020-07-15
First Post:
2018-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2018-08-20', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Yellow Zone episodes', 'timeFrame': '44 weeks', 'description': 'defined by the occurrence of any of the following: (1) Symptom Diary score \\> 4 and (2) ATAQ score \\> 1'}], 'secondaryOutcomes': [{'measure': 'Red Zone episodes', 'timeFrame': '44 weeks', 'description': 'defined by the occurrence of any of the following:\n\nED or Urgent Care visit Administration of systemic (oral, IM, or IV) corticosteroids Hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma, children, spirometry, lung function, asthma action plan, asthma exacerbation, self management'], 'conditions': ['Asthma Acute', 'Asthma in Children', 'Asthma Chronic', 'Asthma Attack']}, 'descriptionModule': {'briefSummary': 'The primary goal of this proposal is to use an in-home, smartphone-enabled, hand-held spirometer to determine the FEV1% predicted ranges that predict the Yellow Zone threshold.', 'detailedDescription': "The study hypothesizes that objective lung function tracking at-home, using a portable spirometer in addition to conventional symptom monitoring (in which asthmatic patients self-report and track their own symptoms), will result in more reliable detection of exacerbation in children 6-15 years old with asthma.\n\nThis is a 44-week, single arm, blinded nonrandomized trial to determine clinically relevant ranges in FEV1% predicted that correlate with the Yellow Zone of the Asthma Action Plan.\n\nA total of 100 pediatric subjects (between the ages of 6 and 15 years old) with physician-diagnosed mild or moderate persistent asthma treated on controller therapy will be enrolled from the ED, Inpatient Units, Pulmonary Medicine Clinic, and Allergy/Immunology Clinic at UCSF Benioff Children's Hospital San Francisco.\n\nPrimary Specific Aim\n\nTo determine the FEV1% predicted changes that correspond with a change from the Green to Yellow Zone.\n\nThe primary outcome will be Yellow Zone episodes, as identified by the occurence of any of the following:\n\nSymptom Diary score \\> 4 ATAQ score \\> 1\n\nSecondary Specific Aim\n\nTo determine the FEV1% predicted changes that correspond with a change from the Yellow to Red Zone.\n\nThe secondary outcome will Red Zone episodes, as identified by the occurence of any of the following:\n\nED or Urgent Care visit Administration of systemic (oral, IM, or IV) corticosteroids Hospitalization"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children 6 to15 years old with mild to moderate persistent asthma seen in the outpatient clinic', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Physician-diagnosed mild or moderate persistent asthma\n2. On controller therapy \\[inhaled corticosteroid (ICS), ICS + leukotriene receptor antagonist (LTRA), or ICS + long-acting beta agonist (LABA)\\] for at least the previous six months\n3. At least one severe exacerbation requiring systemic corticosteroids in the previous year\n4. Baseline FEV1 \\>/= 70% predicted for age, gender, and height according to published reference standards\n5. Parental consent and the child's assent\n\nExclusion Criteria:\n\n1. Chronic obstructive respiratory disorder other than asthma (e.g., cystic fibrosis, primary ciliary dyskinesia)\n2. Severe persistent asthma, as evidenced by any of the following:\n\n * 3 hospitalizations\n * 6 severe exacerbations in the previous year on chronic oral corticosteroid therapy daily symptoms\n3. Inability to perform acceptable spirometry\n4. History of collapsed lung\n5. History of syncope with forced exhalation\n6. Not owning an iOS™ device (e.g., iPhone®, iPod®, or iPad®)\n7. Lacking access to wireless local area networking (Wi-Fi™)"}, 'identificationModule': {'nctId': 'NCT03642418', 'briefTitle': 'User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients Phase 2', 'orgStudyIdInfo': {'id': '17-22946'}}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF- Benioff Children Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Ngoc P Ly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}