Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)

Completed · Phase 3

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.

Key facts

Study ID

NCT01044459

Run by

AstraZeneca

People needed

605

Starts

2009-11-01

Expected to finish

2011-04-01

Last updated by the study team

2017-04-20

Who can join

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

You may qualify if…

• A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
• Current or former cigarette smokers

You may not qualify if…

• Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
• Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
• Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
• History or presence of asthma verified from medical records
• Chronic use of oxygen therapy greater than or equal to 15 hours per day
• Patient with uncontrolled infection due to HIV and/or active hepatitis
• Patients with a history of hypersensitivity reaction to inhaled anticholinergics
• Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.

Where it is running

• Forest Investigative Site 1127 — Mobile, Alabama, United States
• Forest Investigative Site 1475 — Scottsdale, Arizona, United States
• Forest Investigative Site 1338 — Tempe, Arizona, United States
• Forest Investigative Site 1349 — Tucson, Arizona, United States
• Forest Investigative Site 1483 — Buena Park, California, United States
• Forest Investigative Site 1350 — Foothill Ranch, California, United States
• Forest Investigative Site 1509 — Fresno, California, United States
• Forest Investigative Site 2065 — Fullerton, California, United States
• Forest Investigative Site 1502 — Huntington Park, California, United States
• Forest Investigative Site 1088 — Lakewood, California, United States
• Forest Investigative Site 1534 — Long Beach, California, United States
• Forest Investigative Site 2209 — Los Angeles, California, United States
• Forest Investigative Site 1122 — Orange, California, United States
• Forest Investigative Site 1508 — Palm Springs, California, United States
• Forest Investigative Site 2064 — Riverside, California, United States
• Forest Investigative Site 1533 — Sacramento, California, United States
• Forest Investigative Site 2009 — San Diego, California, United States
• Forest Investigative Site 1439 — San Diego, California, United States
• Forest Investigative Site 1503 — San Diego, California, United States
• Forest Investigative Site 1347 — San Jose, California, United States
• Forest Investigative Site 1344 — Spring Valley, California, United States
• Forest Investigative Site 2039 — Walnut Creek, California, United States
• Forest Investigative Site 2037 — Fort Collins, Colorado, United States
• Forest Investigative Site 1327 — Wheat Ridge, Colorado, United States
• Forest Investigative Site 1162 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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