Astrazeneca Dunkerque Production SCS

Primary objective: To evaluate the effect of triple therapy (BGF MDI 320/14.4/9.6 μg) compared with bronchodilator dual therapy (GFF MDI 14.4/9.6 μg) on severe cardiopulmonary outcomes in COPD population not receiving ICS. Secondary objectives: To evaluate the effect of triple therapy (BGF MDI 320/14.4/9.6 μg) compared with bronchodilator dual therapy (GFF MDI 14.4/9.6 μg) on: 1. Severe COPD exacerbations. 2. Severe cardiac events. 3. Cardiopulmonary death. 4. Moderate/severe COPD exacerbations. 5. Time to hospitalization (or cardiac death) for MI. 6. Time to emergency department visit/hospitalization (or cardiac death) for HF in COPD population not receiving ICS. Exploratory objective: To evaluate the effect of triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on: 1. All-cause mortality. 2. Effect on CV events. 3. Effect on unplanned use of health care resources. Safety objective: To evaluate the safety and tolerability of BGF MDI and GFF MDI

Primary objective: To evaluate the effectiveness of BDA MDI on-demand administration compared with AS MDI on the risk of severe asthma exacerbations. Secondary objectives: To evaluate the effectiveness of BDA MDI on-demand administration compared with AS MDI on severe asthma exacerbations and SCS exposure; To evaluate the effects of BDA MDI on-demand administration compared with AS MDI on PROs. Safety objective: To evaluate the safety and tolerability of BDA MDI on-demand administration compared with AS MDI. Exploratory objective: To evaluate the effectiveness of BDA MDI on-demand administration compared with AS MDI on PROs, symptoms, and lung function.

To evaluate the effects and safety of BGF MDI compared with BFF MDI or Symbicort pMDI on lung function, PROs and symptoms in participants with inadequately controlled asthma.