A Study in Patients With Chronic Obstructive Pulmonary Disease

Phase 3 Completed 373 enrolled Chiesi Farmaceutici S.p.A.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2011-04
Primary completion: 2012-03
Completion: 2012-03

Outcome

Met primary endpoint

paper BDP/FF was equivalent to FP/S in terms of TDI score and superior in terms of FEV1 change from pre-dose (p < 0.001). PMID 24621109 ↗

Publications

Results Singh D, Nicolini G, Bindi E, Corradi M, Guastalla D, Kampschulte J, Pierzchala W, Sayiner A, Szilasi M, Terzano C, Vestbo J; FUTURE (Foster Upgrades TherapeUtic care in REspiratory disease) study group. Extrafine beclomethasone/formoterol compared to fluticasone/salmeterol combination therapy in COPD. BMC Pulm Med. 2014 Mar 12;14:43. doi: 10.1186/1471-2466-14-43.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Beclomethasone	Small molecule	200 ug	Inhaled
Comparator	Fluticasone	Other / unclassified	500 ug	Inhaled
Subject	Formoterol	Other / unclassified	12 ug	Inhaled
Comparator	Salmeterol	Other / unclassified	50 ug	Inhaled