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)

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: COPD

Treatments: Drug: aclidinium bromide placebo; Drug: aclidinium bromide 400 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01636401

DW_EKL001

Details and patient eligibility

About

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).

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

0 participants in 2 patient groups, including a placebo group

aclidinium bromide

Active Comparator group

Treatment:

Drug: aclidinium bromide 400 μg

Placebo

Placebo Comparator group

Treatment:

Drug: aclidinium bromide placebo