12 / 48 wk Pivotal PFT vs PBO in COPD II

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo; Drug: Olodaterol (BI 1744)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00782509

1222.12

2008-003704-67 (EudraCT Number)

Details and patient eligibility

About

This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).

Enrollment: 644 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients must have a diagnosis of chronic obstructive pulmonary disease
• Male or female patients, 40 years of age or older Patients must be current or ex-smokers with a smoking history of more than 10 pack years Post bronchodilator FEV1 <80% predicted and post-bronchodilator FEV1/FVC <70%

Exclusion criteria

• Patients with a significant disease other than COPD
• Patients with a history of asthma
• Patients with any of the following conditions:

a history of myocardial infarction within 1 year of screening visit (Visit 1) unstable or life-threatening cardiac arrhythmia. have been hospitalized for heart failure within the past year. known active tuberculosis a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) a history of life-threatening pulmonary obstruction a history of cystic fibrosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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644 participants in 3 patient groups, including a placebo group

Olodaterol (BI1744) Low

Experimental group

Description:

Low dose inhaled orally once daily from the Respimat inhaler

Treatment:

Drug: Olodaterol (BI 1744)

Drug: Olodaterol (BI 1744)

Placebo

Placebo Comparator group

Description:

Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler

Treatment:

Drug: Placebo

Olodaterol (BI 1744) High

Experimental group

Description:

High dose inhaled orally once daily from the Respimat inhaler

Treatment:

Drug: Olodaterol (BI 1744)

Drug: Olodaterol (BI 1744)