Last reviewed · How we verify
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
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.
Details
| Lead sponsor | Chiesi Farmaceutici S.p.A. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 457 |
| Start date | 2005-08 |
| Completion | 2006-10 |
Conditions
- Chronic Obstructive Pulmonary Disease
Interventions
- Formoterol
- Formoterol
Primary outcomes
- 12-hour post-morning dose average FEV1 (area under the FEV1 versus time curve divided by 12 hours) after 12 weeks of treatment — Every 6 weeks
Countries
Poland