Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT00397267
Status:
UNKNOWN
Last Update Posted:
2006-11-28
First Post:
2006-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Acute Asthma in ER With Combination of Systemic Steroids and Inhaled Steroids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2007-12'}, 'lastUpdateSubmitDate': '2006-11-26', 'studyFirstSubmitDate': '2006-11-08', 'studyFirstSubmitQcDate': '2006-11-08', 'lastUpdatePostDateStruct': {'date': '2006-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFT improvment'}, {'measure': 'Admission rate'}]}, 'conditionsModule': {'keywords': ['Dyspnea', 'Cough'], 'conditions': ['Asthma Exacerbation']}, 'descriptionModule': {'briefSummary': 'We assume that the combination of systemic steroids and inhaled steroid in the first hour of treatment in the ER will decrease the admission rate and improve faster the pulmonary function.\n\n120 patients refferd to the ER due to asthma attack aged 18-60 with PFR \\< 60% 0o predicted will participate in the study after giving informed consent.\n\nThe usual treatment in the ER is inhalation of Beta 2 short acting and I.V solumedrol 120 mg . The study group will recieve in addition 3 inhalation of Budesonide 1000 microgram each during the first hour.\n\nThe controlled group will recieve Nacl 0.9% PFR will be followed 0 30 60 120 min.', 'detailedDescription': 'Primary end points- PFT improvment and admission rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asthmatic patients aged 18-60 with PFR \\< 60% of predicted\n\nExclusion Criteria:\n\n* Patients with other chronic diseases\n* cardiac renal hepatic etc will be excluded'}, 'identificationModule': {'nctId': 'NCT00397267', 'briefTitle': 'Treatment of Acute Asthma in ER With Combination of Systemic Steroids and Inhaled Steroids', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'orgStudyIdInfo': {'id': 'SOR440906CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'inhalation of corticosteroids', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P.O.Box 151', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'ER Soroka Med Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'centralContacts': [{'name': 'Dov Heimer M.D. Heimer, AS. Proffessor', 'role': 'CONTACT', 'email': 'heimerd@clalit.org.il', 'phone': '972 8 6400807'}, {'name': 'LUNA Avnon, M.D', 'role': 'CONTACT', 'phone': '972 8 6403024'}], 'overallOfficials': [{'name': 'Dov Heimer, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BGU Soroka medical center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}}}}