NCT00476099

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 828 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI	Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) two puffs via oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
DRUG	Budesonide 200 µg plus formoterol 6 µg DPI	two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.
DRUG	Formoterol 12 µg DPI	one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-08-01
• Completion: 2008-11-01
• First posted: 2007-05-21
• Last updated: 2021-10-29

Locations

1 site across 1 country: France