NCT00972140

Formoterol-HFA 3-month Study in Chronic Obstructive Pulmonary Disease (COPD) Patients

A 3-month, Double-blind, Double-dummy, Randomised, Multinational, Multicenter, 2-arm Parallel-group Study Comparing the Efficacy and Safety of Formoterol-HFA pMDI 12µg Twice Daily and Formoterol-DPI 12µg Twice Daily, in Patients With Stable Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the clinical equivalence of formoterol-HFA pMDI 12µg/actuation administered twice daily to formoterol DPI 12µg/capsule delivered by the Aerolizer inhaler and administered twice daily in patients with COPD.

Detailed description

Phase III, multicenter, multinational, double-blind, double-dummy, randomised, 2-arm parallel-group, 3-month study in patients with stable COPD. Comparison in terms of efficacy and safety of the two formulations of formoterol administered as 24µg/day in a bid regimen

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Formoterol	Formoterol-HFA pMDI 12µg twice daily
DRUG	Formoterol	Formoterol-DPI 12 µg twice daily

Timeline

• Start date: 2005-08-01
• Primary completion: 2006-04-01
• Completion: 2006-10-01
• First posted: 2009-09-04
• Last updated: 2011-12-13

Locations

1 site across 1 country: Poland