Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma

Exclusion Criteria

• •History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk;
• •Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and/or during the run-in period ;
• •Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine;
• •Asthma subjects currently treated with any of the following :
• •1. High dose ICS;
• •2. Long-acting muscarinic antagonist (LAMA);
• •3. Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;
• •4. Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;
• •5. Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening;
• •Respiratory disorders other than asthma
• •Lung resection;
• •Lower respiratory tract infection;
• •Lung cancer and history of lung cancer;
• •Subjects with active cancer or a history of cancer (other than lungs) ;
• •Patients who have clinically significant cardiovascular condition;
• •Run-in compliance: e-Diary completion \<75% and run-in treatment compliance \<75% at randomisation;