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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Budesonide; Formoterol Fumarate

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