Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)

Overview

The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.

Full Title of Study: “Efficacy and Safety of Aclidinium Bromide at Two Dose Levels (200 μg Twice Daily, 400 μg Twice Daily) vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2009

Interventions

  • Drug: Aclidinium bromide
    • Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment
  • Drug: Aclidinium bromide
    • Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment
  • Drug: Placebo
    • Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment

Arms, Groups and Cohorts

  • Experimental: 1
    • Aclidinium bromide dose, inhaled, for 12 weeks of treatment
  • Experimental: 2
    • Aclidinium bromide dose, inhaled, for 12 weeks of treatment
  • Placebo Comparator: 3
    • Inhaled placebo for 12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
    • Time Frame: Change from Baseline to 12 weeks
    • Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)

Secondary Measures

  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)
    • Time Frame: Change from Baseline to 12 weeks
    • Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)

Participating 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, 2009; 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: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Esther Garcia, MD, Study Director, AstraZeneca

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