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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: single dose of 20 mcg; Drug: single dose of placebo; Drug: single dose of 40 mcg; Drug: single dose of 10 mcg; Drug: single dose of 5 mcg; Drug: single dose of 2 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01809262

1222.3

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 6 patient groups, including a placebo group

olodaterol 2 mcg

Experimental group

Description:

solution for inhalation

Treatment:

Drug: single dose of 2 mcg

olodaterol 5 mcg

Experimental group

Description:

solution for inhalation

Treatment:

Drug: single dose of 5 mcg

olodaterol 10 mcg

Experimental group

Description:

solution for inhalation

Treatment:

Drug: single dose of 10 mcg

olodaterol 20 mcg

Experimental group

Description:

solution for inhalation

Treatment:

Drug: single dose of 20 mcg

olodaterol 40 mcg

Experimental group

Description:

solution for inhalation

Treatment:

Drug: single dose of 40 mcg

placebo

Placebo Comparator group

Description:

solution for inhalation

Treatment:

Drug: single dose of placebo