Study identifier:LAS-MD-35
ClinicalTrials.gov identifier:NCT01044459
EudraCT identifier:N/A
CTIS identifier:N/A
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
Chronic Obstructive Pulmonary Disease
Phase 3
No
Aclidinium Bromide 200 µg, Aclidinium Bromide 400 µg
All
605
Interventional
40 Years +
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Feb 2017 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
Location
Location
Birmingham, AL, United States, 35209
Location
Mobile, AL, United States, 36608
Location
Scottsdale, AZ, United States, 85258
Location
Tempe, AZ, United States, 85282
Location
Tucson, AZ, United States, 85710
Location
Buena Park, CA, United States, 90620
Location
Foothill Ranch, CA, United States, 92610
Location
Fresno, CA, United States, 93720
Arms | Assigned Interventions |
---|---|
Experimental: Aclidinium Bromide 200 µg aclidinium bromide, inhaled, 52 weeks of treatment | Drug: Aclidinium Bromide 200 µg aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment |
Experimental: Aclidinium Bromide 400 µg aclidinium bromide, inhaled, 52 weeks of treatment | Drug: Aclidinium Bromide 400 µg aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment |
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