protocolSection identificationModule nctId: NCT06297668, orgStudyIdInfo id: D5985C00008, briefTitle: A Study to Assess the Pharmacokinetics and Safety 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: 2024-04-26, primaryCompletionDateStruct date: 2024-06-13, completionDateStruct date: 2024-06-13, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, 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: 42, 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 locations facility: Research Site, city: Berlin, zip: 14050, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, city: Harrow, zip: HA1 3UJ, country: United Kingdom, geoPoint lat: 51.57142, lon: -0.33371, hasResults: False