nctId: NCT06264674 id: CLI-05993AB6-03 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 overallStatus: RECRUITING date: 2023-11-27 date: 2024-08-25 date: 2025-09-18 date: 2024-02-20 date: 2024-02-20 name: Chiesi Farmaceutici S.p.A. class: INDUSTRY 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. conditions: Asthma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 790 type: ESTIMATED name: CHF5993 200/6/12.5 μg pMDI HFA-152a name: Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a 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) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1) 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) 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) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1) measure: Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period measure: Percentage of days without intake of rescue medication. measure: Change in the average daily use of rescue medication. measure: Change on the average daily asthma symptoms. measure: Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score. measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of Adverse Events (AEs) / Adverse Drug Reactions (ADRs). measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of number of Adverse Events (AEs) of particular interest. measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of incident rate of Adverse Events (AEs) of particular interest. measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of rate ration of Adverse Events (AEs) of particular interest. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital status: RECRUITING city: Manchester zip: M23 9QZ country: United Kingdom name: Dave Singh, MD role: CONTACT lat: 53.48095 lon: -2.23743 hasResults: False