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)

NCT00476099 Phase 3 COMPLETED

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.

Details

Lead sponsor	Chiesi Farmaceutici S.p.A.
Phase	Phase 3
Status	COMPLETED
Enrolment	828
Start date	2006-12
Completion	2008-11

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

• Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
• Budesonide 200 µg plus formoterol 6 µg DPI
• Formoterol 12 µg DPI

Primary outcomes

• Number of COPD exacerbations and pre-dose morning FEV1 — one year treatment

Countries

France