Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.

Key facts

Study ID

NCT01045161

Run by

AstraZeneca

People needed

544

Starts

2009-03-01

Expected to finish

2011-06-01

Last updated by the study team

2017-01-23

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, 2008; 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 1419 — Birmingham, Alabama, United States
• Forest Investigative Site 1413 — Muscle Shoals, Alabama, United States
• Forest Investigative Site 1353 — Pell City, Alabama, United States
• Forest Investigative Site 1379 — Phoenix, Arizona, United States
• Forest Investigative Site 2065 — Fullerton, California, United States
• Forest Investigative Site 1451 — National City, California, United States
• Forest Investigative Site 1388 — Paramount, California, United States
• Forest Investigative Site 1424 — Rolling Hill Estates, California, United States
• Forest Investigative Site 1427 — Sacramento, California, United States
• Forest Investigative Site 1418 — 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 1331 — Vista, California, United States
• Forest Investigative Site 1380 — Golden, Colorado, United States
• Forest Investigative Site 1447 — Pueblo, Colorado, United States
• Forest Investigative Site 1364 — Clearwater, Florida, United States
• Forest Investigative Site 1516 — Edgewater, Florida, United States
• Forest Investigative Site 1403 — Hollywood, Florida, United States
• Forest Investigative Site 1485 — Homestead, Florida, United States
• Forest Investigative Site 1352 — Miami, Florida, United States
• Forest Investigative Site 1391 — Naples, Florida, United States
• Forest Investigative Site 1376 — Port Orange, Florida, United States
• Forest Investigative Site 1372 — South Miami, Florida, United States
• Forest Investigative Site 1407 — Trinity, Florida, United States
• Forest Investigative Site 1493 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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