The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
291
Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
Forest Investigative Site 1162
Birmingham, Alabama, United States
Forest Investigative Site 1127
Mobile, Alabama, United States
Forest Investigative Site 0909
Glendale, Arizona, United States
Forest Investigative Site 2060
Phoenix, Arizona, United States
Forest Investigative Site 2065
Fullerton, California, United States
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Change From Baseline (Visit 2 of lead-in Study NCT00891462, \[LAS-MD-33\]) to Week 52 (Week 64 From Start of NCT00891462, \[LAS-MD-33\]) in Morning Predose (Trough) FEV1
Time frame: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks
Change From Baseline in Peak FEV1
Change From Baseline (Visit 2 of study NCT00891462, \[LAS-MD-33\])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, \[LAS-MD-33\]).
Time frame: 52 weeks
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Forest Investigative Site 1088
Lakewood, California, United States
Forest Investigative Site 1122
Orange, California, United States
Forest Investigative Site 2029
Rancho Mirage, California, United States
Forets Investigative Site 2064
Riverside, California, United States
Forest Investigative Site 0517
Sacramento, California, United States
...and 73 more locations