protocolSection identificationModule nctId: NCT06340581, orgStudyIdInfo id: D5985C00009, secondaryIdInfos id: 2023-509914-12, type: OTHER, domain: EU CT, briefTitle: A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) Hydrofluoroolefin (HFO) With a Spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) With a Spacer (Treatment A), as Well as BGF MDI HFO Without a Spacer (Treatment C)., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-17, primaryCompletionDateStruct date: 2024-10-28, completionDateStruct date: 2024-10-28, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Parexel, descriptionModule briefSummary: The purpose of this study is to assess the bioequivalence of the lung exposure of budesonide, glycopyrronium, and formoterol administered as budesonide, glycopyrronium, formoterol (BGF) metered dose inhaler (MDI) hydrofluoroolefin (HFO) with AeroChamber Plus Flow-Vu spacer compared with BGF MDI hydrofluoroalkane (HFA) with AeroChamber Plus Flow Vu spacer And BFG MDI HFO (Spacer vs No Spacer)., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: Treatment A: BGF MDI HFA, interventions name: Treatment B: BGF MDI HFO, interventions name: Treatment C: BGF MDI HFO, interventions name: AeroChamber Plus Flow-Vu Spacer, outcomesModule primaryOutcomes measure: Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI, primaryOutcomes measure: Maximum Observed Concentration (Cmax) of BGF MDI, secondaryOutcomes measure: Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast), secondaryOutcomes measure: Maximum Observed Concentration (Cmax), secondaryOutcomes measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf), secondaryOutcomes measure: Time to Reach Maximum Observed Concentration (tmax), secondaryOutcomes measure: Terminal Rate Constant (λz), secondaryOutcomes measure: Half-life Associated with Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz), secondaryOutcomes measure: Mean Residence Time of the Unchanged Drug in the Systemic Circulation from Zero to Infinity (MRTinf), secondaryOutcomes measure: Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F), secondaryOutcomes measure: Apparent Volume of Distribution at Steady State Following Extravascular Administration (Vz/F), secondaryOutcomes measure: Number of Participants with Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False