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

Prior treatment

• 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 ;
• Lung resection;

Other illness

• Respiratory disorders other than asthma
• 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;

Lab values

• Asthma subjects currently treated with any of the following :
  • High dose ICS;
  • Long-acting muscarinic antagonist (LAMA);
  • Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;
  • Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;
  • Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening;

Other

• Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine;
• Run-in compliance: e-Diary completion \<75% and run-in treatment compliance \<75% at randomisation;

• Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years;
• Non-smokers, ex-smokers;
• Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive;
• Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with:
  • low or medium doses of ICS (Inhaled Corticosteroids) alone; or
  • low or medium doses of ICS + LABA (Long-acting β2-agonist) (fixed or free combination).
• Controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score \<1.5 at screening and at randomisation.
• Pre-BD (Bronchodilator) FEV1 \>40% and \<90% of the predicted normal value, after appropriate wash out from BDs, at the Screening Visit (V1).
• A demonstrated increase in either FEV1 or forced vital capacity of \>12% and \>200 mL from baseline within 30 minutes (min) after inhalation of 400 µg salbutamol (i.e. albuterol) pMDI at the Screening Visit (V1).