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

Launched by CHIESI FARMACEUTICI S.P.A. · May 18, 2007

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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