Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Olodaterol; Pharmaceutical Solutions

Criteria

Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease

2. Smoking history of more than 10-pack years

Exclusion criteria:

1. History of asthma, allergic rhinitis, myocardial infarction or unstable of life-threatening cardiac arrhythmias

2. Marked baseline prolongation of QT/QTc interval