Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients with Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

Study identifier:LAC-MD-36

ClinicalTrials.gov identifier:NCT01572792

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 3

Healthy volunteers

No

Study drug

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

Sex

All

Actual Enrollment

921

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Apr 2012
Primary Completion Date: 01 Jun 2013
Study Completion Date: 01 Jun 2013

Study design

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

Verification:

Verified 01 Feb 2017 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria