protocolSection identificationModule nctId: NCT06264674, orgStudyIdInfo id: CLI-05993AB6-03, secondaryIdInfos id: 2023-503333-22-00, type: OTHER, domain: EMA CTIS, briefTitle: Comparison Between CHF5993 pMDI 200/6/12,5mg HFA-152a VS CHF5993 pMDI 200/6/12,5mg HFA-134a in Subjects With Asthma (Trecos), acronym: TRECOS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-27, primaryCompletionDateStruct date: 2024-08-25, completionDateStruct date: 2025-09-18, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Chiesi Farmaceutici S.p.A., class: INDUSTRY, descriptionModule briefSummary: The CLI-05993AB6-03 Study is an interventional study designed to compare potential for bronchoconstriction, safety and tolerability profile using of HFA 152a propellant versus using to HFA 134a., conditionsModule conditions: Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 790, type: ESTIMATED, armsInterventionsModule interventions name: CHF5993 200/6/12.5 μg pMDI HFA-152a, interventions name: Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a, outcomesModule primaryOutcomes measure: Relative change from pre-dose Forced Expiratory Volume in one second with (FEV1) (Safety Assessment to evaluate of the potential bronchoconstriction of the study treatment), secondaryOutcomes measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1), secondaryOutcomes measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1), secondaryOutcomes measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (number and percentage of subjects with a relative decrease from pre-dose in FEV1), secondaryOutcomes measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Absolute and relative changes from baseline in pre-dose FEV1), secondaryOutcomes measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1), secondaryOutcomes measure: Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period, secondaryOutcomes measure: Percentage of days without intake of rescue medication., secondaryOutcomes measure: Change in the average daily use of rescue medication., secondaryOutcomes measure: Change on the average daily asthma symptoms., secondaryOutcomes measure: Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score., otherOutcomes measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of Adverse Events (AEs) / Adverse Drug Reactions (ADRs)., otherOutcomes measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of number of Adverse Events (AEs) of particular interest., otherOutcomes measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of incident rate of Adverse Events (AEs) of particular interest., otherOutcomes measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of rate ration of Adverse Events (AEs) of particular interest., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital, status: RECRUITING, city: Manchester, zip: M23 9QZ, country: United Kingdom, contacts name: Dave Singh, MD, role: CONTACT, geoPoint lat: 53.48095, lon: -2.23743, hasResults: False