Study to Patients With Stable COPD to Assess the Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate (DUAKLIR) (AVANT)

This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide/Formoterol fumarate compared with individual components and placebo and Aclidinium bromide compared with Placebo when administered to patients with stable Chronic Obstructive Pulmonary Disease (COPD).


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 1060 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 24-week Treatment, Randomised, Parallel-group, Double Blinded, Double-Dummy, Multicenter Study to Assess the Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Compared With Individual Components and Placebo and Aclidinium Bromide Compared With Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.
Actual Study Start Date: January 24, 2017
Estimated Primary Completion Date: June 30, 2020
Estimated Study Completion Date: June 30, 2020

Arms:
- Experimental: Experimental 1 (Aclidinium bromide 400μg/Formoterol fumarate 12 μg)
- Experimental: Experimental 2 (Aclidinium bromide 400 μg)
- Active Comparator: Comparator (Formoterol fumarate 12 μg)
- Placebo Comparator: Placebo