Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT01044459
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 605
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aclidinium Bromide 400 µg Aclidinium Bromide 400 µg aclidinium bromide, inhaled, 52 weeks of treatment Aclidinium Bromide 200 µg Aclidinium Bromide 200 µg aclidinium bromide, inhaled, 52 weeks of treatment
- Primary Outcome Measures
Name Time Method Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) From baseline to 52 weeks Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Peak FEV1 52 weeks Change From Baseline in Peak FEV1 in liters at Week 52.
Trial Locations
- Locations (113)
Forest Investigative Site 1162
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 1127
🇺🇸Mobile, Alabama, United States
Forest Investigative Site 1475
🇺🇸Scottsdale, Arizona, United States
Forest Investigative Site 1338
🇺🇸Tempe, Arizona, United States
Forest Investigative Site 1349
🇺🇸Tucson, Arizona, United States
Forest Investigative Site 1483
🇺🇸Buena Park, California, United States
Forest Investigative Site 1350
🇺🇸Foothill Ranch, California, United States
Forest Investigative Site 1509
🇺🇸Fresno, California, United States
Forest Investigative Site 2065
🇺🇸Fullerton, California, United States
Forest Investigative Site 1502
🇺🇸Huntington Park, California, United States
Scroll for more (103 remaining)Forest Investigative Site 1162🇺🇸Birmingham, Alabama, United States