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)



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:6/10/2016
Start Date:April 2012
End Date:June 2013

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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)

The purpose of this Phase III study is to evaluate the long-term safety and tolerability of
two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium
bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic
Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and
health-related quality of life assessments will also be evaluated. This extension study will
include a 28 week treatment period, followed by a four week follow up visit. All patients
will remain in the same treatment group as for the lead-in study and continue on one of the
four treatment arms or placebo.


Inclusion Criteria:

- Completion of the treatment phase of the lead-in study, LAC-MD-31

- Written informed consent obtained from the patient before the initiation of any study
specific procedures

- No medical contraindication as judged by the PI

- Compliance with LAC-MD-31 study procedures and IP dosing.

Exclusion Criteria:

- No specific exclusion criteria
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