Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: BI 1744 (Olodaterol) Medium Dose; Drug: BI 1744 (Olodaterol) Low Dose; Drug: Foradil; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00932646

1222.25

Details and patient eligibility

About

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.

Enrollment: 100 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 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 use
• 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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100 participants in 4 patient groups, including a placebo group

BI1744 (Olodaterol)

Experimental group

Description:

Medium Dose once Daily

Treatment:

Drug: BI 1744 (Olodaterol) Medium Dose

BI 1744 (Olodaterol)

Experimental group

Description:

Low Dose once Daily

Treatment:

Drug: BI 1744 (Olodaterol) Low Dose

Placebo

Placebo Comparator group

Description:

Placebo once Daily

Treatment:

Drug: Placebo

Foradil

Active Comparator group

Description:

12 mcg twice daily

Treatment:

Drug: Foradil