Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Bromides; Olodaterol; Tiotropium Bromide

Criteria

Inclusion criteria:

• Patients willing to participate with confirmed diagnosis of COPD

• 40 years of age or older

• having a 10 pack year smoking history

• able to perform serial pulmonary function tests

• able to use both a Dry powder inhaler (DPI) and Respimat device

Exclusion criteria:

• Significant other disease

• clinically relevant abnormal hematology, chemistry, or urinalysis

• history of asthma

• diagnosis of thyrotoxicosis

• paroxysmal tachycardia related to beta agonists

• history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year

• active tuberculosis, cystic fibrosis, clinically evident bronchiectasis

• significant alcohol or drug abuse

• pulmonary resection

• taking oral beta adrenergics

• taking unstable oral steroids

• daytime oxygen

• enrolled in rehabilitation program

• enrolled in another study or taking investigational products

• pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control

• those who are not willing to comply with pulmonary medication washouts