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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01636401

Enrollment

Unknown

Registered

2012-07-10

Start date

2012-08-31

Completion date

2013-05-31

Last updated

2013-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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).

Interventions

DRUGaclidinium bromide 400 μg

DRUGaclidinium bromide placebo

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 12 in morning predose (trough) FEV1	Week 12

Secondary

Measure	Time frame
Change from baseline to Week 12 in peak FEV1	Week 12

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026