Asthma Clinical Trials

• 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).