Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients

Inclusion criteria

• ✓. Patient's written informed consent obtained prior to any study-related procedures;
• ✓. Male or female patients aged \>=18;
• ✓. Patients with persistent asthma not optimally controlled (GINA 2010 'Management Approach Based on Control') on high doses of ICS (1000-2000 μg daily dose BDP non-extrafine or equivalent) or medium doses of ICS+LABA (500-1000 μg daily dose BDP non-extrafine or equivalent plus formoterol 24 μg or salmeterol 100 μg) at a stable dose for at least 4 weeks prior to screening; Equivalence to Medium dose High dose BDP non-extrafine 500-1000 μg \> 1000-2000 μg BDP extrafine 200-400 μg \> 400-800 μg Budesonide 400-800 μg \> 800-1600 μg Ciclesonide 160-320 μg \> 320-1280 μg Fluticasone 250-500 μg \> 500-1000 μg Mometasone 400-800 μg \> 800-1200 μg
• ✓. Patients with a FEV1 \> = 40% and \< 80% of patient's predicted normal value and an absolute value of at least 0.9 L, after appropriate washout from bronchodilators at screening and at the end of the run-in period;
• ✓. Patients with a positive response to the reversibility test at screening, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI. In case this reversibility threshold was not met, the FEV1 reversibility test could be performed once before randomisation, after an appropriate wash-out from bronchodilators. Alternatively, a documented positive response to reversibility, as defined above, within the 3 months prior to the screening visit was acceptable;
• ✓. Patients with not adequately controlled asthma evidenced by:
• ✓. Presence of at least 7 available pre-dose morning PEF measurements in the run-in period;
• ✓. Patients with a cooperative attitude and ability to be trained to correctly use the pMDI and a portable electronic peak flow meter;

Exclusion criteria