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

NCT ID: NCT01809262

Last Updated: 2014-06-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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olodaterol 2 mcg

solution for inhalation

Group Type EXPERIMENTAL

single dose of 2 mcg

Intervention Type DRUG

solution for inhalation

olodaterol 5 mcg

solution for inhalation

Group Type EXPERIMENTAL

single dose of 5 mcg

Intervention Type DRUG

solution for inhalation

olodaterol 10 mcg

solution for inhalation

Group Type EXPERIMENTAL

single dose of 10 mcg

Intervention Type DRUG

solution for inhalation

olodaterol 20 mcg

solution for inhalation

Group Type EXPERIMENTAL

single dose of 20 mcg

Intervention Type DRUG

solution for inhalation

olodaterol 40 mcg

solution for inhalation

Group Type EXPERIMENTAL

single dose of 40 mcg

Intervention Type DRUG

solution for inhalation

placebo

solution for inhalation

Group Type PLACEBO_COMPARATOR

single dose of placebo

Intervention Type DRUG

solution for inhalation

Interventions

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single dose of 5 mcg

solution for inhalation

Intervention Type DRUG

single dose of placebo

solution for inhalation

Intervention Type DRUG

single dose of 40 mcg

solution for inhalation

Intervention Type DRUG

single dose of 20 mcg

solution for inhalation

Intervention Type DRUG

single dose of 2 mcg

solution for inhalation

Intervention Type DRUG

single dose of 10 mcg

solution for inhalation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1222.3.1 Atrium medisch centrum

Heerlen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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1222.3

Identifier Type: -

Identifier Source: org_study_id