protocolSection identificationModule nctId: NCT06290102, orgStudyIdInfo id: TV56248-RES-10204, 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-10-02, completionDateStruct date: 2024-11-09, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Teva Branded Pharmaceutical Products R&D, Inc., class: INDUSTRY, descriptionModule briefSummary: The primary objectives of this study are:* 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* 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)* To compare the PK profiles of ABS between the 2 different strengths of TEV-56248The secondary objective is:• To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI, conditionsModule conditions: Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: TEV-56248, interventions name: Fp MDPI, outcomesModule primaryOutcomes measure: Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp), primaryOutcomes measure: Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS), primaryOutcomes 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, primaryOutcomes 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, primaryOutcomes measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp, primaryOutcomes measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS, primaryOutcomes measure: Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp, primaryOutcomes measure: Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS, primaryOutcomes measure: Last Measurable Concentration Above the Quantification Limit (Clast) of Fp, primaryOutcomes measure: Last Measurable Concentration Above the Quantification Limit (Clast) of ABS, primaryOutcomes measure: Time of Last Measurable Concentration (tlast) of Fp, primaryOutcomes measure: Time of Last Measurable Concentration (tlast) of ABS, secondaryOutcomes measure: Number of Participants with Adverse Events (AEs), secondaryOutcomes measure: Number of Participants with Serious Adverse Events (SAEs), secondaryOutcomes measure: Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs), eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: Teva Investigational Site 12001, status: RECRUITING, city: Boerne, state: Texas, zip: 78006, country: United States, geoPoint lat: 29.79466, lon: -98.73197, hasResults: False