2-arm Parallel Group Study of Fixed Combination of CHF 5993 vs Ultibro® in COPD Patients

Inclusion Criteria

• •Inclusion :
• •1. Male and female ≥ 40 years
• •2. Severe or very severe COPD diagnosed for at least 12 months
• •3. Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years
• •4. Post-bronchodilator FEV1 \< 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio \< 0.7
• •5. Documented history of at least one exacerbation in the 12 months
• •6. Patient under double therapy for at least 2 months prior to screening. Double therapy will be defined by treatment with any of the following:
• •Orally inhaled corticosteroid (ICS) and (long-acting beta2-agonist) LABA ICS and long-acting muscarinic antagonist (LAMA) Orally LABA and LAMA Monotherapy with LAMA for at least 2 months prior to screening
• •7. Symptomatic patient at screening with a CAT score ≥ 10.
• •8. Cooperative attitude and ability to use correctly the inhalers, the spacer AeroChamber Plus (only to patients who are using a spacer), the electronic devices with COPD questionnaire.
• •Exclusion :
• •1. Pregnant or lactating women and all women physiologically capable of becoming pregnant UNLESS are willing to use one or more of the reliable methods of contraception
• •2. Patient with a current clinical diagnosis of asthma with a physician-judged need for inhaled or oral corticosteroid therapy
• •3. Patient requiring use of the following medications:
• •Course of systemic steroids \> 3 days for COPD exacerbation in the 4 weeks prior to screening Course of antibiotics for COPD exacerbation \> 7 days in the 4 weeks prior to screening Phosphodiesterase-4 inhibitor in the 4 weeks prior to screening Use of antibiotics for a lower respiratory tract infection in the 4 weeks prior to screening
• •4. COPD exacerbation requiring prescription of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period
• •5. Patient treated with non-cardioselective β-blockers in the month preceding the screening or during the run-in period.
• •6. Patient treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as needed
• •7. Patient requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
• •8. Known respiratory disorders other than COPD which may impact the efficacy of the study drug
• •9. Patient who have clinically significant cardiovascular condition
• •10. Patient with atrial fibrillation (AF): Paroxysmal atrial fibrillation, Persistent, Long standing or Permanent
• •11. Abnormal and clinically significant 12-lead ECG that results in active medical problem which may impact the safety of the patient