Efficacy and Safety of 400 μg Twice Daily of Aclidinium Bromide vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2012
CompletedFirst Posted
Study publicly available on registry
July 10, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedAugust 21, 2013
August 1, 2013
9 months
July 6, 2012
August 20, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline to Week 12 in morning predose (trough) FEV1
Week 12
Secondary Outcomes (1)
Change from baseline to Week 12 in peak FEV1
Week 12
Study Arms (2)
aclidinium bromide
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity \[FVC\] ratio \< 70% and FEV1 ≥ 30% to \<80% of the predicted value.
- Current or former cigarette smokers with a smoking history of at least 10 pack-years.
You may not qualify if:
- History or current diagnosis of asthma
- Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1
- Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1.
- Patients with any clinically significant respiratory conditions other than COPD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
Lee SH, Lee J, Yoo KH, Uh ST, Park MJ, Lee SY, Kim JY, Kim DK, Kim SJ, Lee KH, Yoo CG. Efficacy and safety of aclidinium bromide in patients with COPD: A phase 3 randomized clinical trial in a Korean population. Respirology. 2015 Nov;20(8):1222-8. doi: 10.1111/resp.12641. Epub 2015 Sep 15.
PMID: 26370136DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2012
First Posted
July 10, 2012
Study Start
August 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
August 21, 2013
Record last verified: 2013-08