Efficacy of LAMA Added to ICS in Treatment of Asthma (ELITRA)

Inclusion criteria

• ✓. Patient's written informed consent obtained prior to any study related procedures;
• ✓. Male or female patients aged ≥18 and ≤75 years;
• ✓. History of asthma ≥5 year and diagnosed before the age of 40 years;
• ✓. Patients with uncontrolled asthma on low medium doses of ICS (200 - 1000 μg daily dose BDP non-extrafine or estimated clinical comparable dose) at a stable dose for at least 4 weeks prior to Screening visit;
• ✓. Patients with a pre bronchodilator FEV1 ≥40% and \<90% of their predicted normal value, after appropriate washout from bronchodilators, at Screening visit and the end of the run in period;
• ✓. Patients with a positive response to the reversibility test at Screening visit within 30 minutes after administration of 400 μg of salbutamol pMDI, defined as ΔFEV1 ≥12% and ≥200 mL over baseline; Note: In case this reversibility threshold was not met, the test could have been performed once before randomisation.
• ✓. Patients with uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire® (ACQ) ≥1.5 (criterion had to be met at Screening visit and the end of the run in period);
• ✓. Patients with a co-operative attitude and ability to be trained to correctly use the pMDI and the electronic peak flow meter (e-peak flow meter). At the Screening visit (V1), all the above mentioned inclusion criteria were checked. At the Randomisation visit (V2), the following inclusion criteria were re checked: 5, 7 and 8.