Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT00695604
Status:
WITHDRAWN
Last Update Posted:
2018-05-08
First Post:
2008-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Repeated High-dose Inhaled Corticosteroids for Asthma
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was not able to be completed, no results analyzed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2008-06-10', 'studyFirstSubmitQcDate': '2008-06-11', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airflow inflammation.', 'timeFrame': 'Pre-study and post-study drug administration'}], 'secondaryOutcomes': [{'measure': 'Airflow obstruction.', 'timeFrame': 'Pre-study and post-study drug administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute asthma', 'fluticasone', 'inhaled corticosteroids'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids (ICS) vs. placebo in adults with chronic stable asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Physician diagnosis of asthma.\n* Age ≥18 years and ≤50 years\n* Evidence of airflow obstruction as measured by spirometry and flow-volume loop per American Thoracic Society guidelines.\n* Treatment for asthma with:\n\n * daily inhaled corticosteroids and long-acting beta2-agonists, AND\n * as-needed use of a short-acting beta2-agonist\n\nExclusion criteria:\n\n* History of \\>10 pack-year tobacco use\n* Other pulmonary or cardiac diagnosis that is actively being treated\n* History of adverse events or allergy to fluticasone\n* Systemic corticosteroid therapy within 7 days of study visit\n* Inability to obtain written informed consent'}, 'identificationModule': {'nctId': 'NCT00695604', 'acronym': 'ReHICS', 'briefTitle': 'Repeated High-dose Inhaled Corticosteroids for Asthma', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Repeated High-dose Inhaled Corticosteroids for Asthma', 'orgStudyIdInfo': {'id': '15322B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo Comparator\n\nAll patients assigned to this group will receive:\n\n1. Placebo via Metered Dose Inhaler (MDI).\n2. Albuterol via MDI.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Active Comparator\n\nAll patients assigned to this group will receive:\n\n1. Fluticasone via MDI.\n2. Albuterol via MDI.', 'interventionNames': ['Drug: Fluticasone']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo via MDI.', 'armGroupLabels': ['1']}, {'name': 'Fluticasone', 'type': 'DRUG', 'description': 'Fluticasone MDI.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jerry Krishnan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}