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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636401
First Posted: July 10, 2012
Last Update Posted: August 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
  Purpose
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).

Condition Intervention Phase
COPD Drug: aclidinium bromide 400 μg Drug: aclidinium bromide placebo Phase 3

Study Type: Interventional
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • Change from baseline to Week 12 in morning predose (trough) FEV1 [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • Change from baseline to Week 12 in peak FEV1 [ Time Frame: Week 12 ]

Study Start Date: August 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: aclidinium bromide Drug: aclidinium bromide 400 μg
Placebo Comparator: Placebo Drug: aclidinium bromide placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636401


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01636401     History of Changes
Other Study ID Numbers: DW_EKL001
First Submitted: July 6, 2012
First Posted: July 10, 2012
Last Update Posted: August 21, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Anticonvulsants