A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED,

INTERVENTION: Product Name: CHF 5259 pMDI Pharmaceutical Form: Pressurised inhalation, solution INN or Proposed INN: GLYCOPYRRONIUM BROMIDE CAS Number: 596‐51‐0 Other descriptive name: SUB07951MIG Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 12.5‐ Pharmaceutical form of the placebo: Pressurised inhalation, solution Route of administration of the placebo: Inhalation use CONDITION: Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] uncontrolled asthma ; MedDRA version: 17.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 ‐ Respiratory, thoracic and mediastinal disorders PRIMARY OUTCOME: Main Objective: To evaluate the superiority of CHF 5259 pMDI (glycopyrrolate bromide) (50 µg total daily dose) versus placebo in terms of FEV1 AUC0‐12h normalised by time on Day 42.; Primary end point(s): FEV1 AUC0‐12h normalised by time on Day 42 Secondary Objective: Key Secondary objective; To evaluate the superiority of CHF 5259 pMDI (50 µg total daily dose) versus placebo in terms of peak FEV1 on Day 42.; ; Secondary objectives; ? To evaluate the effect of CHF 5259 on other lung function parameters and on clinical outcome measures.; ? To assess the safety and tolerability of study treatments. Timepoint(s) of evaluation of this end point: Day 42; SECONDARY OUTCOME: Secondary end point(s): Change from baseline in peak FEV1 . ; Safety (Adverse Events and Adverse Drug Reactions) ; Timepoint(s) of evaluation of this end point: Day 42 ; (across the study for the safety) INCLUSION CRITERIA: 1. Patient’s written informed consent obtained prior to any study‐related procedures 2. Male or female patients aged =18 and =75 years. 3. History of asthma = 5‐year and diagnosed before the age of 40 years. 4. Patients with uncontrolled asthma on low‐medium doses of Inhaled Corticosteroid (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. 5. Patients with a pre‐bronchodilator FEV1 =40% and <90% of their predicted normal value, after appropriate washout from bronchodilators, at screening and at the end of the run‐in period. 6. Patients with a positive response to the reversibility test at screening within 30 minutes after administration of 400 µg of salbutamol pMDI, defined as ?FEV1 = 12% and = 200mL over baseline. 7. Patients with uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire© (ACQ) =1.5 (criterion must be met a