Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 3:13 PM
Study NCT ID:
NCT01556958
Status:
TERMINATED
Last Update Posted:
2013-08-19
First Post:
2012-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WheezoMeter® Correlation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001988', 'term': 'Bronchiolitis'}], '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'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Device revised', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-16', 'studyFirstSubmitDate': '2012-03-15', 'studyFirstSubmitQcDate': '2012-03-16', 'lastUpdatePostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Asthma', 'Bronchiolitis']}, 'descriptionModule': {'briefSummary': "The primary goal of the study is to more firmly establish correlations between WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including spirometry, provider's auscultation, and symptoms at the time of Wz% measurement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric Specialty Clinic', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients \\<= 12 years of age who have wheezing at the time of study as confirmed by the physicians' auscultation.\n\nControl:\n\n* Patients \\<= 12 years of age without history of asthma or other pulmonary conditions, and who are without wheezing on physical exam.\n\nExclusion Criteria:\n\n* Medical problems that would contraindicate Wz% measurement."}, 'identificationModule': {'nctId': 'NCT01556958', 'briefTitle': 'WheezoMeter® Correlation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'iSonea'}, 'officialTitle': 'Prospective Comparative Study of WheezeRATE™ (Wz%) Readings With Spirometry, Symptoms, and Auscultatory Findings in Children With Wheezing.', 'orgStudyIdInfo': {'id': 'iS-2012-Wz'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active Wheezing - age 5-12'}, {'label': 'Active Wheezing - under age 5'}, {'label': 'No Wheezing'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95630', 'city': 'Folsom', 'state': 'California', 'country': 'United States', 'facility': 'Site 1', 'geoPoint': {'lat': 38.67796, 'lon': -121.17606}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iSonea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}