12 / 48 Week Pivotal PFT vs PBO in COPD I

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Olodaterol (BI1744); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00782210

1222.11

2008-003647-36 (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).

The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo.

Enrollment: 625 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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625 participants in 3 patient groups, including a placebo group

Olodaterol (BI 1744) Low

Experimental group

Description:

Low dose inhaled orally once daily from the Respimat inhaler

Treatment:

Drug: Olodaterol (BI1744)

Drug: Olodaterol (BI1744)

Olodaterol (BI 1744) High

Experimental group

Description:

High dose inhaled orally once daily from the Respimat inhaler

Treatment:

Drug: Olodaterol (BI1744)

Drug: Olodaterol (BI1744)

Placebo

Placebo Comparator group

Description:

Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler

Treatment:

Drug: placebo