Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT00479258
Status:
TERMINATED
Last Update Posted:
2018-10-01
First Post:
2007-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C473734', 'term': 'Exubera'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Pfizer announced Oct07 it would stop marketing Exubera; recruitment placed on hold. Nektar, from which Pfizer licensed Exubera, announced April 9, 2008 it had stopped its search for a new marketing partner. Study terminated; no further recruitment.'}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inhaled Insulin (Exubera)', 'description': 'No subjects received study medication.'}, {'id': 'OG001', 'title': "Subcutaneous Insulin (Subject's Prescribed)", 'description': 'No subjects received study medication.'}], 'timeFrame': '12 months', 'description': 'No subjects were dosed therefore no data collected.', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects were dosed therefore no participants for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Other PFT Parameters', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Treatment Preferences.', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FVC', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Slope for Other PFT Parameters;', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin Antibodies (microU/mL);', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Hypoglycemic Event Rates;', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': '7 Point Home Glucose', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inhaled Insulin (Exubera)', 'description': 'No subjects received study medication.'}, {'id': 'FG001', 'title': "Subcutaneous Insulin (Subject's Prescribed)", 'description': 'No subjects received study medication.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Two subjects completed the informed consent/assent process and entered the A2171083 study but none received treatment. The first subject withdrew consent during the Baseline Run-in period which was prior to Randomization. The second subject screen failed at Visit 1. Location = UNITED STATES.', 'preAssignmentDetails': 'Pfizer announced in Oct 2007 that it would stop marketing Exubera. At that time recruitment was placed on hold. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. As a result, study A2171083 was terminated and no further recruitment took place.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inhaled Insulin (Exubera)', 'description': 'No subjects received study medication.'}, {'id': 'BG001', 'title': "Subcutaneous Insulin (Subject's Prescribed)", 'description': 'No subjects received study medication.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'description': '\\<18 years', 'unitOfMeasure': 'subjects'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-31', 'studyFirstSubmitDate': '2007-05-24', 'resultsFirstSubmitDate': '2008-10-29', 'studyFirstSubmitQcDate': '2007-05-24', 'lastUpdatePostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2008-10-31', 'studyFirstPostDateStruct': {'date': '2007-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2008-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period', 'timeFrame': '12 months', 'description': 'No subjects were dosed therefore no data collected.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Other PFT Parameters', 'timeFrame': '12 months'}, {'measure': 'Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;', 'timeFrame': '12 months'}, {'measure': 'Treatment Preferences.', 'timeFrame': '12 months'}, {'measure': 'Change From Baseline in FVC', 'timeFrame': '12 months'}, {'measure': 'Slope for Other PFT Parameters;', 'timeFrame': '12 months'}, {'measure': 'Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c', 'timeFrame': '12 months'}, {'measure': 'Change From Baseline in Insulin Antibodies (microU/mL);', 'timeFrame': '12 months'}, {'measure': 'Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;', 'timeFrame': '12 months'}, {'measure': 'Hypoglycemic Event Rates;', 'timeFrame': '12 months'}, {'measure': '7 Point Home Glucose', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171083&StudyName=Safety%20And%20Efficacy%20Of%20Exubera%20Compared%20With%20Subcutaneous%20Human%20Insulin%20Therapy%20In%20Children%20And%20Adolescents', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period.', 'detailedDescription': 'Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for the pediatric study, A2171083, was placed on hold. Two subjects completed the informed consent/assent process and entered the A2171083 study but none received treatment. The first subject withdrew consent during the Baseline Run-in period which was prior to Randomization. The second subject screen failed at Visit 1. After this time, Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171083 was terminated and no further recruitment took place.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with Type 1 diabetes mellitus for more than 6 months.\n* Males and females ages 6 to 17 years.\n* Subjects should be receiving, or be able to tolerate, at a minimum a 3 unit pre prandial dose of short acting subcutaneous insulin.\n\nExclusion Criteria:\n\n* Subjects using an insulin pump\n* Smoking'}, 'identificationModule': {'nctId': 'NCT00479258', 'briefTitle': 'Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Safety And Efficacy Of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents Ages 6-17 Years With Type 1 Diabetes Mellitus: A 12 Month, Outpatient, Randomized, Open Label, Parallel Group Comparative Trial.', 'orgStudyIdInfo': {'id': 'A2171083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhaled insulin (Exubera)', 'interventionNames': ['Drug: Inhaled insulin (Exubera)']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Subcutaneous Insulin (subject's prescribed)", 'interventionNames': ["Drug: Subcutaneous Insulin (subject's prescribed)"]}], 'interventions': [{'name': 'Inhaled insulin (Exubera)', 'type': 'DRUG', 'description': 'Inhaled insulin with dose adjusted according to premeal blood glucose', 'armGroupLabels': ['Inhaled insulin (Exubera)']}, {'name': "Subcutaneous Insulin (subject's prescribed)", 'type': 'DRUG', 'description': 'Subcutaneous insulin with dose adjusted according to premeal blood glucose', 'armGroupLabels': ["Subcutaneous Insulin (subject's prescribed)"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '14222', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}