The purpose of this study is to evaluate the efficacy of Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide Administered Via Dry Powder Inhaler in COPD

Inclusion Criteria:

• Male and female adults (40 ≤ age ≤ 85 years) with a diagnosis of COPD;

• Current smokers or ex-smokers;

• A Post-bronchodilator FEV1 ≥30% and <80% of the predicted normal value and FEV1/FVC (Forced Vital Capacity) < 0.7;

• Patients' COPD therapy (stable regimen at least 30 days before screening) with either:

  • Inhaled corticosteroids/long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination
  • Inhaled corticosteroids/long-acting β2-agonist (free or fixed) combination
  • Inhaled long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination
  • Inhaled long-acting muscarinic antagonist alone.

Exclusion Criteria:

• Pregnant and lactating women;
• Diagnosis of asthma;
• Known respiratory disorders other than COPD;
• Patients treated for a moderate or severe COPD exacerbation within 6 weeks prior to screening or during the run-in period;
• Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia;
• Patients who have clinically significant cardiovascular condition;

Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.