A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01908140 Phase 3 COMPLETED Results posted

The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)

Details

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	COMPLETED
Enrolment	933
Start date	2013-09
Completion	2014-08

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

• Aclidinium Bromide / Formoterol Fumarate
• Salmeterol / Fluticasone

Primary outcomes

• Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 — At Week 24
  Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration

Countries

Austria, Bulgaria, Canada, Czechia, France, Germany, Hungary, Italy, Lithuania, Netherlands, Poland, South Africa, Spain, United Kingdom