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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:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01636401
First received: July 6, 2012
Last updated: August 20, 2013
Last verified: August 2013

July 6, 2012
August 20, 2013
August 2012
May 2013   (final data collection date for primary outcome measure)
Change from baseline to Week 12 in morning predose (trough) FEV1 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Change from baseline to Week 12 in morning predose (trough) FEV1 [ Time Frame: Week 12 ]
Complete list of historical versions of study NCT01636401 on ClinicalTrials.gov Archive Site
Change from baseline to Week 12 in peak FEV1 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Change from baseline to Week 12 in peak FEV1 [ Time Frame: Week 12 ]
Not Provided
Not Provided
 
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)
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)

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).

Not Provided
Interventional
Phase 3
Not Provided
COPD
  • Drug: aclidinium bromide 400 μg
  • Drug: aclidinium bromide placebo
  • Active Comparator: aclidinium bromide
    Intervention: Drug: aclidinium bromide 400 μg
  • Placebo Comparator: Placebo
    Intervention: Drug: aclidinium bromide placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01636401
DW_EKL001
Not Provided
Daewoong Pharmaceutical Co. LTD.
Daewoong Pharmaceutical Co. LTD.
Not Provided
Not Provided
Daewoong Pharmaceutical Co. LTD.
August 2013

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