Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT06290102
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2024-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp)', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS)', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'Area Under the Plasma Drug Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Fluticasone Propionate', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'AUC0-24 of Albuterol Sulfate', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'Last Measurable Concentration Above the Quantification Limit (Clast) of Fp', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'Last Measurable Concentration Above the Quantification Limit (Clast) of ABS', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'Time of Last Measurable Concentration (tlast) of Fp', 'timeFrame': 'Up to 24 hours postdose'}, {'measure': 'Time of Last Measurable Concentration (tlast) of ABS', 'timeFrame': 'Up to 24 hours postdose'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to 2 Months'}, {'measure': 'Number of Participants with Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 2 Months'}, {'measure': 'Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 2 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are:\n\n* To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module \\[Fp/ABS eMDPI\\]) in participants with asthma\n* To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI)\n* To compare the PK profiles of ABS between the 2 different strengths of TEV-56248\n\nThe secondary objective is:\n\n• To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI', 'detailedDescription': 'The planned duration for this trial is approximately 1.5 to 3 months. The trial includes a 14-day screening period, 3 treatment periods (2 days each), and a follow up visit 7 days after end of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant has a diagnosis of asthma as defined by the Global Initiative for Asthma guidelines (GINA 2023), which has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days before the Screening Visit\n* Has persistent asthma, with a forced expiratory value (FEV1) that is greater than or equal to 80% of the value predicted for age, height, sex, and race at the Screening Visit\n* Demonstrate acceptable inhalation technique with the training inhaler\n* Able to stop (as judged by the Investigator) his or her rescue medication, for approximately 6 hours before the Screening Visit and for approximately 4 hours before training sessions in periods 1-3\n* Has body mass index (BMI) within the 3rd and 97th percentiles for the participant's age and gender. The participant must have a weight of ≥18 kilograms (kg)\n* Able to achieve a peak inspiratory flow (PIF) rate of at least 60 liters per minute (L/min) on an inhaler training device\n\nNOTE- Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* Participant has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures\n* Has participated as a randomized participant in any investigational drug trial within 30 days (starting from the final follow-up visit of that trial) preceding the Screening Visit or plans to participate in another investigational drug trial at any time during this trial\n* Known hypersensitivity to any corticosteroid, albuterol, or any of the ingredients in the investigational medicinal product\n* Asthma exacerbation requiring systemic corticosteroids within 30 days of the Screening Visit, or has had any hospitalization for asthma within 2 months of the Screening Visit\n\nNOTE- Additional criteria apply, please contact the investigator for more information"}, 'identificationModule': {'nctId': 'NCT06290102', 'briefTitle': 'Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'An Open Label, Single Dose, 3-Period, Crossover Study to Determine the Pharmacokinetic Profile and Safety of Fluticasone Propionate/Albuterol Sulfate (Fp/ABS) Multidose Dry Powder Inhaler With e-Module (eMDPI) Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Participants With Asthma (4 to 11 Years Old)', 'orgStudyIdInfo': {'id': 'TV56248-RES-10204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence ABC', 'interventionNames': ['Drug: TEV-56248', 'Drug: Fp MDPI']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence BCA', 'interventionNames': ['Drug: TEV-56248', 'Drug: Fp MDPI']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence CAB', 'interventionNames': ['Drug: TEV-56248', 'Drug: Fp MDPI']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence ACB', 'interventionNames': ['Drug: TEV-56248', 'Drug: Fp MDPI']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence BAC', 'interventionNames': ['Drug: TEV-56248', 'Drug: Fp MDPI']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence CBA', 'interventionNames': ['Drug: TEV-56248', 'Drug: Fp MDPI']}], 'interventions': [{'name': 'TEV-56248', 'type': 'DRUG', 'otherNames': ['- fluticasone propionate/albuterol sulfate multidose dry powder inhaler with e-module (Fp/ABS eMDPI)'], 'description': 'Pharmaceutical form: Dry powder\n\nRoute of administration: Oral inhalation', 'armGroupLabels': ['Sequence ABC', 'Sequence ACB', 'Sequence BAC', 'Sequence BCA', 'Sequence CAB', 'Sequence CBA']}, {'name': 'Fp MDPI', 'type': 'DRUG', 'otherNames': ['- fluticasone propionate multidose dry powder inhaler'], 'description': 'Pharmaceutical form: Dry powder\n\nRoute of administration: Oral inhalation', 'armGroupLabels': ['Sequence ABC', 'Sequence ACB', 'Sequence BAC', 'Sequence BCA', 'Sequence CAB', 'Sequence CBA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 12010', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '90815', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 12003', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '33130', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 12007', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33142', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 12005', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 12002', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '70508', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Teva Investigational Site 12008', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 12011', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '73120-9389', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Teva Investigational Site 12012', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '78006', 'city': 'Boerne', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 12001', 'geoPoint': {'lat': 29.79466, 'lon': -98.73197}}, {'zip': '78249', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 12009', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Teva Medical Expert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc.'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicalstudydatarequest.com/', 'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}