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



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:4/21/2016
Start Date:December 2009
End Date:June 2011

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A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.
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