A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Olodaterol (BI1744) Low; Drug: Placebo (for Tiotropium); Drug: Olodaterol (BI1744) High; Drug: Placebo (for Olodaterol (BI1744)l); Drug: Tiotropium 18 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01040728

2009-014418-86 (EudraCT Number)

1222.40

Details and patient eligibility

About

The study is intended to characterize the lung function profile of BI1744 in Chronic Obstructive Pulmonary Disease (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.

Enrollment: 122 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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122 participants in 4 patient groups, including a placebo group

Olodaterol (BI1744) Low

Experimental group

Description:

Low dose inhaled orally once daily from Respimat inhaler

Treatment:

Drug: Olodaterol (BI1744) Low

Olodaterol (BI1744) High

Experimental group

Description:

High dose inhaled orally once daily from Respimat inhaler

Treatment:

Drug: Olodaterol (BI1744) High

Tiotropium 18 mcg

Active Comparator group

Description:

18 mcg inhaled once daily from HandiHaler

Treatment:

Drug: Tiotropium 18 mcg

Placebo

Placebo Comparator group

Description:

Olodaterol placebo and/or Tiotropium placebo inhaled once daily

Treatment:

Drug: Placebo (for Tiotropium)

Drug: Placebo (for Olodaterol (BI1744)l)