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)

Last updated: August 20, 2013
Sponsor: Daewoong Pharmaceutical Co. LTD.
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01636401
DW_EKL001
  • Ages > 40
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A diagnosis of stable moderate to severe COPD as defined by GOLD (the GlobalInitiative 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

Exclusion Criteria:

  • History or current diagnosis of asthma

  • Patients who have been hospitalized for an acute COPD exacerbation within 3 monthsprior to Visit 1

  • Any respiratory tract infection (including the upper respiratory tract) or COPDexacerbation in the 6 weeks before Visit 1.

  • Patients with any clinically significant respiratory conditions other than COPD

Study Design

Study Start date:
August 01, 2012
Estimated Completion Date:
May 31, 2013

Connect with a study center

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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