Casey Medical Consulting (Shanghai) Co., Ltd.

Primary objective: To demonstrate the non-inferiority of CHF1535pMDI to Symbicort in lung function (change from baseline in forced expiratory volume in one second (FEV1) before morning dosing at week 24) in patients with COPD. Secondary objectives: To assess the effect of CHF1535pMDI on other lung function parameters and patient-reported outcomes (PROs). To assess the safety and tolerability of the study treatment.

Primary Objectives: To evaluate the pharmacokinetics of beclomethasone dipropionate (BDP), beclomethasone-17 monopropionate (B17MP), formoterol, and picoplatin bromide (GB) after single and repeated administration of CHF5993 pMDI at therapeutic doses and after single administration of CHF5993 pMDI at supratherapeutic doses in healthy Chinese subjects. Secondary Objectives: To assess systemic effects (systolic blood pressure [SBP], diastolic blood pressure [DBP], heart rate [HR], QTcF) within 12 hours after morning administration of CHF 5993 pMDI on days 1 and 7 at therapeutic doses and on day 1 at supratherapeutic doses. To assess the safety and tolerability of study treatments.

Primary objective: To demonstrate superiority over Symbicort in terms of lung function (changes from baseline in morning FEV1 before dosing and morning FEV1 2 hours after dosing at week 24) Key secondary objectives: To demonstrate superiority over Symbicort in terms of lung function (changes from baseline in morning FEV1 before dosing and morning FEV1 2 hours after dosing at week 24) in the Chinese subgroup population. Other secondary objectives: To evaluate the effects on other lung function parameters, patient health status and clinical outcome measures; to evaluate the safety and tolerability of the study drug, etc.