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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.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Forest Investigative Site 1827
Anniston, Alabama, United States
Forest Investigative Site 1920
Athens, Alabama, United States
Forest Investigative Site 1162
Birmingham, Alabama, United States
Forest Investigative Site 1493
Birmingham, Alabama, United States
Forest Investigative Site 1937
Birmingham, Alabama, United States
Forest Investigative Site 1824
Gulf Shores, Alabama, United States
Forest Investigative Site 2088
Jasper, Alabama, United States
Forest Investigative Site 1918
Scottsboro, Alabama, United States
Forest Investigative Site 0909
Glendale, Arizona, United States
Forest Investigative Site 1379
Phoenix, Arizona, United States
Start Date
April 1, 2012
Primary Completion Date
June 1, 2013
Completion Date
June 1, 2013
Last Updated
April 21, 2017
921
ACTUAL participants
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
DRUG
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
DRUG
Aclidinium bromide
DRUG
Formoterol Fumarate
DRUG
Placebo
DRUG
Lead Sponsor
AstraZeneca
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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