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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)

NCT ID: NCT01636401

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-05-31

Brief Summary

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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

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Conditions

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COPD

Study Groups

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aclidinium bromide

Group Type ACTIVE_COMPARATOR

aclidinium bromide 400 μg

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

aclidinium bromide placebo

Intervention Type DRUG

Interventions

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aclidinium bromide 400 μg

Intervention Type DRUG

aclidinium bromide placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 26370136 (View on PubMed)

Other Identifiers

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DW_EKL001

Identifier Type: -

Identifier Source: org_study_id