Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium bromide; Placebo
Intervention description: Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment.; Dose-matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo will receive open label 400 µg aclidinium bromide for 40 weeks of treatment
Intervention MeSH terms: Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 544.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; COPD; Chronic Bronchitis; Emphysema; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease

Summary:

      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.
    

Eligibility criteria:

        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.