Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT06171932
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-15
First Post:
2023-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D006854', 'term': 'Hydrocortisone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-23', 'size': 386638, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-12-05T22:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-08-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2023-11-24', 'studyFirstSubmitQcDate': '2023-12-12', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spirometry', 'timeFrame': '24 hours', 'description': 'Above will be check on arrival of patient to Emergency and post Managment'}, {'measure': 'Blood pressures', 'timeFrame': '24 hours', 'description': 'Vital signs at initial presentation and post managment will be recorded Blood pressure in mm HG will be recorded'}, {'measure': 'Respiratory rate', 'timeFrame': '24 hours', 'description': 'Respiratory rate at arrival and post managment will be considered Respiratory rate in Breaths/min'}, {'measure': 'Heart rate', 'timeFrame': '24 hours', 'description': 'Heart rate beats/min will be checked'}, {'measure': 'PEAK EXPIRATORY FLOW RATE', 'timeFrame': '24 hours', 'description': 'it wil be checked on arrival and post managment in Peak Expiratory Flow rate (force expiratory volume in 1 second and force vital capacity )will be examined'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma Acute']}, 'referencesModule': {'references': [{'pmid': '20930966', 'type': 'RESULT', 'citation': 'Aggarwal P, Bhoi S. Comparing the efficacy and safety of two regimens of sequential systemic corticosteroids in the treatment of acute exacerbation of bronchial asthma. J Emerg Trauma Shock. 2010 Jul;3(3):231-7. doi: 10.4103/0974-2700.66522.'}], 'seeAlsoLinks': [{'url': 'https://journals.lww.com/onlinejets/fulltext/2010/03030/comparing_the_efficacy_and_safety_of_two_regimens.5.aspx', 'label': 'Comparision'}]}, 'descriptionModule': {'briefSummary': 'COMPARISON OF EFFICACY OF HYDROCORTISONE AND METHYLPREDNISOLONE IN ACUTE SEVERE ASTHMA\n\nIn this study Investigator will compare the efficacy of hydrocortisone and methyl prednisolone in acute severe asthma that will lead to final result and beneficial effects that will help in early resoloution of symptoms and help in preventing recurrence', 'detailedDescription': 'investigator will compare the efficacy of hydrocortisone v/s methylprednisolone in management of patients presented with acute severe asthma in emergency.\n\nA local study was conducted in 2009, after that there is a big research gap exists at national level although international literature is available on the same but it can not be generalized to our population due to socio, geographic and economic differences so there is dire need to conduct this study this gives a strong rationale to implement in our settings'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 30 in each group', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Either Gender (18 to 50 years old)\n* Patient presenting to emergency department with acute severe asthma\n\nExclusion Criteria:\n\n* Patients with critical illness or pregnant females. .Patient treated other than hydrocortisone and methylprednisolone. .Patients not willing to participate in study.\n* Life threatening asthma\n* Near fatal asthm'}, 'identificationModule': {'nctId': 'NCT06171932', 'briefTitle': 'Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma', 'organization': {'class': 'OTHER', 'fullName': 'University of Karachi'}, 'officialTitle': 'Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma', 'orgStudyIdInfo': {'id': 'Zia ud din university karachi'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HYDROCORTISONE', 'description': 'Group A will comprise of 30 patients will be treated with 200 mg hydrocortisone followed by 3 doses of hydrocortisone 100 mg 6 hours apart for next 24hrs'}, {'label': 'METHYLPREDNISOLONE', 'description': 'Group B will be treated with methylprednisolone 125 mg stat', 'interventionNames': ['Drug: Methylprednisolone,']}], 'interventions': [{'name': 'Methylprednisolone,', 'type': 'DRUG', 'otherNames': ['Hydrocortisone'], 'description': 'No intervention required', 'armGroupLabels': ['METHYLPREDNISOLONE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09323', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Zia ud din hospital university', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '09323', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Zia ud din university hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Zia ud din university hospitals', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Zia ud din university', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Inayat ur Rehman, MD ER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'zia ud din university karachi'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '6 MONTHS', 'ipdSharing': 'YES', 'description': 'PERFORMA OF PATIENTS AND DATA TAKEN FROM HOSPITAL OF KARACHI WILL BE SHARED AS WELL RESULT OUTCOME WILL BE SHARED IT WILL INCLUDE STUDY PROTOCOL STATS INFORMED CONSENT CLINICAL STUDY REPORT', 'accessCriteria': 'IPD CRITERIA WILL SHARE WHEN REQUIRED DIRECTLY FROM INVESTIGASTOR'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Karachi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Inayat Ur Rehman', 'investigatorAffiliation': 'University of Karachi'}}}}