A 12-week, Multicentre, Randomised, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® 100/6 (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Puffs b.i.d., Versus Symbicort® 200/6 (Budesonide 200 µg Plus Formoterol 6 µg/Actuation), 2 Inhalations b.i.d., on Parameters of Small Airway Function in Patients With Chronic Obstructive Pulmonary Disease. (FAIR)

NCT01351792 Phase 3 TERMINATED

The purpose of the present study is to demonstrate the higher efficacy of small particles Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations b.i.d.), in terms of residual volume reduction over a 12-week treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients.

Details

Lead sponsor	Chiesi Farmaceutici S.p.A.
Phase	Phase 3
Status	TERMINATED
Enrolment	113
Start date	2011-09
Completion	2012-11

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

• Foster® 100/6 µg/unit dose
• Symbicort® Turbohaler® 200/6 μg/actuation

Primary outcomes

• Change from baseline to end of treatment in post-dose residual volume. — At day 84

Countries

Netherlands