Overview
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 Pu
Status:
Completed
Completed
Trial end date:
2013-06-01
2013-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AstraZenecaTreatments:
BromidesFormoterol Fumarate
Criteria
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