Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD

A 48-week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3-arm Parallel Group Clinical Study of "Fixed Combination" Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus "Fixed Combination" Budesonide Plus Formoterol DPI Versus Formoterol DPI in Patients With Stable Severe Chronic Obstructive Pulmonary Disease (COPD)

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