Triple in Asthma Dose Finding

Inclusion criteria

• ✓. Patient's written informed consent obtained prior to any study-related procedures;
• ✓. Male or female patients aged ≥18;
• ✓. Patients with uncontrolled asthma on 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; Drug\* Medium daily dose BDP non-extrafine \>500 - 1000 μg BDP extrafine \>250 - 500 μg Budesonide \>400 - 800 μg Ciclesonide \>160 - 320 μg Fluticasone \>250 - 500 μg Mometasone ≥400 μg - \< 800 μg
• ✓. Patients with a pre-bronchodilator FEV1 ≥40% and \<80% of their predicted normal value, after appropriate wash-out from bronchodilators, at Screening and at the end of the run-in period;
• ✓. Patients with a positive response to the reversibility test at Screening within 30 minutes after administration of 400 μg of salbutamol pMDI, defined as ΔFEV1 ≥12% and ≥200 mL over Baseline; Note: In case the reversibility threshold is not met, the test can be performed once before randomisation.
• ✓. Patients with uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire® (ACQ) ≥1.5 (criterion must be met at Screening and at the end of the run-in period);
• ✓. Patients with a co-operative attitude and ability to be trained to correctly use the pMDI.

Exclusion criteria