Clinical Research Directory

Inclusion Criteria: * 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: 1. low or medium doses of ICS (Inhaled Corticosteroids) alone; or 2. 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). 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;