Brief Summary

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Official Title: "A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease"

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.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Study Primary Completion Date: April 2011

Interventions Used in this Clinical Trial

• Drug: aclidinium bromide
  • aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
• Drug: aclidinium bromide
  • aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • aclidinium bromide, inhaled, 52 weeks of treatment
• Experimental: 2
  • aclidinium bromide, inhaled, 52 weeks of treatment

Outcome Measures for this Clinical Trial

Primary Measures

• Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
  • Time Frame: From baseline to 52 weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Peak FEV1
  • Time Frame: 52 weeks
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Forest Laboratories
• Collaborator
  • Almirall, S.A.
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Jordan Lateiner, MS, Study Director, Forest Laboratories