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 |
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.
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
We found this trial at
150
sites
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