Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 4:35 AM
Study NCT ID:
NCT00971893
Status:
WITHDRAWN
Last Update Posted:
2018-11-29
First Post:
2009-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Assess The Safety And Effectiveness Of Medrol® In Acute Asthma In Indian 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-27', 'studyFirstSubmitDate': '2009-09-03', 'studyFirstSubmitQcDate': '2009-09-03', 'lastUpdatePostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Relapse within 10 days of hospital discharge (Relapse is defined as unscheduled care at a doctor's office, a clinic, or Emergency Department (ED) for symptoms of persistent or worsening asthma after hospital discharge)", 'timeFrame': '10 days after discharge'}], 'secondaryOutcomes': [{'measure': 'Relapse within 20 days of hospital discharge (Relapse is defined as above for Primary Endpoint).', 'timeFrame': '20 days after discharge'}, {'measure': 'Change in PEFR (Peak Expiratory Flow Rate measured in Percentage of expected) between start of therapy and first follow up visit.', 'timeFrame': '8 - 22 days after discharge'}, {'measure': 'Change in FEV1 (Forced Expiratory Volume in 1 second) between start of therapy and first follow up visit.', 'timeFrame': '8 - 22 days after discharge'}, {'measure': 'Proportion of patients controlled for asthma symptoms in the last 7 days after 10 days of hospital discharge', 'timeFrame': '10 days after discharge'}, {'measure': 'Proportion of patients controlled for asthma symptoms in the last 7 days after 20 days of hospital discharge', 'timeFrame': '20 days after discharge'}, {'measure': 'Change in frequency in last 24 hours of inhalational Beta 2 agonist therapy between start of therapy and first follow up visit', 'timeFrame': '8 - 22 days after discharge'}, {'measure': 'Physician-directed intensification of pharmacologic therapy between discharge from hospital and first follow up visit.', 'timeFrame': '8 - 22 days after discharge'}, {'measure': 'Summary of adverse events in the study', 'timeFrame': 'Baseline to 20 days after discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Exacerbation of Bronchial Asthma Acute Asthma'], 'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0121003&StudyName=A%20Study%20To%20Assess%20The%20Safety%20And%20Effectiveness%20Of%20Medrol%AE%20In%20Acute%20Asthma%20In%20Indian%20Patients', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The present study is designed to collect data on real world experience on use of Medrol in acute asthma in Indian patients.', 'detailedDescription': 'Sequential enrollment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of Acute Asthma who have been prescribed oral Medrol tablets, will be enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be eligible for enrollment in this study, patients must be prescribed oral Medrol® tablets (4mg and 16 mg) for acute asthma as per the locally approved prescribing information. The prescription of Medrol® will be separated from the decision to include the patient in the study.\n* Medrol® tablets, will be prescribed to the patient by the physician according to his/her usual practice. The decision to prescribe Medrol® tablet will necessarily precede and will be independent of the decision to enroll patient into the study. Only those patients who have been prescribed Medrol® tablets will be evaluated for their potential eligibility for the study\n* Only those patients, who are ready and willing to sign an informed consent, will be included in the study\n* Subject can be contacted through telephone\n\nExclusion Criteria:\n\n* Based upon history or physical exam in the emergency department (ED) or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema\n* Any contraindication to Medrol tablet use. Contraindications of Medrol use are systemic fungal infections and known hypersensitivity to components'}, 'identificationModule': {'nctId': 'NCT00971893', 'briefTitle': 'A Study To Assess The Safety And Effectiveness Of Medrol® In Acute Asthma In Indian Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients', 'orgStudyIdInfo': {'id': 'B0121003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Methylprednisolone Group', 'interventionNames': ['Drug: Oral Methylprednisolone Tablets']}], 'interventions': [{'name': 'Oral Methylprednisolone Tablets', 'type': 'DRUG', 'description': 'Oral Methylprednisolone tablets given as per locally approved prescribing information', 'armGroupLabels': ['Methylprednisolone Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}