A 12-week double-blind, multicentre, randomised, active-controlled, 2-arm, parallel-group clinical trial to evaluate the safety of CHF5993 pMDI 200/6/12.5 µg HFA-152a, compared to CHF5993 pMDI 200/6/12.5 µg HFA-134a, in subjects with asthma

Moderate to severe controlled asthma according to Step 4 and Step 5 of the Global Initiative for Asthma (GINA) 2022 Guidelines.

Relative change from pre-dose* in FEV1 at the 10 min post‑dose timepoint on Day 1.

Relative change from pre-dose* in FEV1 at all the post-dose timepoints at each study visit (Day 1, Day 7 and Week 12: 20 min, 30 min, 1 h and 2 h post-dose; Day 7, Week 4 and Week 12: 10 min post-dose);, Absolute change from pre-dose* in FEV1 at all post-dose timepoints at each study visit (Day 1, Day 7, and Week 12: 10 min, 20 min, 30 min, 1 h, and 2 h post-dose; Week 4: 10 min post-dose);, Number and percentage of subjects with a relative decrease from pre-dose* in FEV1 at each post-dose timepoint and at any post-dose timepoint > 15% at each study visit (Day 1, Day 7, and Week 12: 10 min, 20 min, 30 min, 1 h, and 2 h post-dose; Week 4: 10 min post-dose);, Absolute and relative changes from baseline (i.e., pre-dose* FEV1 at Day 1) in pre-dose* FEV1 at all clinical visits;, Change from pre-dose* in FEV1 area under the curve from time zero to 2 h (AUC0-2h) on Day 1, Day 7 and Week 12;, Change from baseline at each inter-visit period and over the entire treatment period in morning and evening PEF;, Change from baseline at each inter-visit period and over the entire treatment period in the percentage of days without intake of rescue medication;, Change from baseline at each inter-visit period and over the entire treatment period in the average daily use of rescue medication (number of inhalations/day);, Change from baseline at each inter-visit period and over the entire treatment period in the average daily symptoms, Change from baseline in ACQ-7 at each study visit;, AEs and adverse drug reactions (ADRs);, AEs of particular interest: cough, dysphonia, paradoxical bronchospasm, hypersensitivity reactions, severe asthma exacerbations according to ATS/ERS criteria, Vital signs (systolic and diastolic blood pressure);, 12-lead ECG parameters: heart rate (HR), QTcF, PR interval (PR) and QRS interval (QRS);, 12-lead ECG abnormalities, Standard haematology and blood chemistry (including serum potassium and glucose);, Chemistry in urine (quantitative [proteins] and qualitative [ketones and microscopic examination of the sediments]).

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