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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT01572792

Run by

AstraZeneca

People needed

921

Starts

2012-04-01

Expected to finish

2013-06-01

Last updated by the study team

2017-04-21

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• No specific exclusion criteria

Where it is running

• 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
• Forest Investigative Site 1822 — Anaheim, California, United States
• Forest Investigative Site 1483 — Buena Park, California, United States
• Forest Investigative Site 1156 — Fresno, California, United States
• Forest Investigative Site 1871 — Lincoln, California, United States
• Forest Investigative Site 1873 — Los Angeles, California, United States
• Forest Investigative Site 2064 — Riverside, California, United States
• Forest Investigative Site 1427 — Sacramento, California, United States
• Forest Investigative Site 1866 — Sacramento, California, United States
• Forest Investigative Site 1125 — San Diego, California, United States
• Forest Investigative Site 2009 — San Diego, California, United States
• Forest Investigative Site 1374 — Torrance, California, United States
• Forest Investigative Site 1813 — Tustin, California, United States
• Forest Investigative Site 1883 — Vista, California, United States
• Forest Investigative Site 1380 — Golden, Colorado, United States
• Forest Investigative Site 1137 — Pueblo, Colorado, United States
• Forest Investigative Site 1827 — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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