A 12-week, Multicentre, Multinational, Randomized, 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 Seretide® 500/50 (Fluticasone 500 µg Plus Salmeterol 50 µg/Actuation), 1 Inhalation b.i.d., in Patients With Chronic Obstructive Pulmonary Disease (FUTURE)

NCT01245569 Phase 3 COMPLETED

The purpose of the present study is to determine the effects on health status and spirometric values of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), 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	COMPLETED
Enrolment	373
Start date	2011-04
Completion	2012-03

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

• Foster® 100/6 µg/unit dose
• Seretide Accuhaler® 500/50 µg/actuation

Primary outcomes

• Transition Dyspnoea Index (TDI) score — At day 84
• Area Under the Curve (AUC) 0-30min standardized by time of change from pre-dose in Forced Expiratory Volume in one second (FEV1) — After drug inhalation in the morning of day 1

Countries

Italy