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 is not yet open for participant recruitment.

Verified July 2012 by Daewoong Pharmaceutical Co. LTD.

Sponsor:

Information provided by (Responsible Party):

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT01636401

First received: July 6, 2012

Last updated: July 12, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 6, 2012

Last Updated Date

July 12, 2012

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change from baseline to Week 12 in morning predose (trough) FEV1 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT01636401 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline to Week 12 in peak FEV1 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change from baseline to Week 12 in peak FEV1 [ Time Frame: Week 12 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

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)

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

COPD

Intervention ^ICMJE

Drug: aclidinium bromide 400 μg
Drug: aclidinium bromide placebo

Study Arm (s)

Active Comparator: aclidinium bromide
Intervention: Drug: aclidinium bromide 400 μg
Placebo Comparator: Placebo
Intervention: Drug: aclidinium bromide placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Chul-Gyu Yoo

cgyoo@snu.ac.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01636401

Other Study ID Numbers ^ICMJE

DW_EKL001

Has Data Monitoring Committee

Not Provided

Responsible Party

Daewoong Pharmaceutical Co. LTD.

Study Sponsor ^ICMJE

Daewoong Pharmaceutical Co. LTD.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Daewoong Pharmaceutical Co. LTD.

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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