To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.

The purpose of this study is to evaluate the long-term efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD. Patients are randomised to receive either beclometasone/formoterol or budesonide/formoterol DPI or formoterol DPI during 48 weeks of treatment.

Inclusion Criteria:

• Clinical diagnosis of COPD (according to GOLD guidelines)
• FEV1 > or equal 30% and < 50% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
• COPD symptoms for at least 2 years
• At least 1 exacerbation requiring medical intervention (oral corticosteroid and/or antibiotic treatment and/or need for a visit to an emergency department and/or hospitalization) within 2-12 months before screening
• Current or previous smoker with a cumulative exposure to smoke of more than 20-pack year

Exclusion Criteria:

• Current or past diagnosis of asthma, or any evidence suggestive of asthma
• Positive FEV1 reversibility test
• Clinically significant or unstable concurrent diseases, including clinically significant laboratory abnormalities
• Acute COPD exacerbation or lower tract infection and/or treatment with oral or injectable corticosteroids and antibiotics in the 2 months before screening or during run-in
• Long term oxygen therapy

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.