Study to assess efficacy and safety of Aclidinium bromide and Aclidinium bromide/Formoterol fumarate in stabile COPD patients - AVANT

Study identifier:D6570C00002

ClinicalTrials.gov identifier:NCT03022097

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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.

Medical condition

COPD

Phase

Phase 3

Healthy volunteers

No

Study drug

Aclidinium bromide/formoterol Fixed-Dose Combination, Aclidinium bromide, Formoterol Fumarate, Placebo

Sex

All

Actual Enrollment

1067

Study type

Interventional

Age

40 Years - 130 Years

Date

Study Start Date: 24 Jan 2017
Primary Completion Date: 14 Apr 2022
Study Completion Date: 14 Apr 2022

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria