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

NCT01809262 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-06-30

Study results available
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Summary

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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

single dose of 5 mcg

solution for inhalation

DRUG

single dose of placebo

solution for inhalation

DRUG

single dose of 40 mcg

solution for inhalation

DRUG

single dose of 20 mcg

solution for inhalation

DRUG

single dose of 2 mcg

solution for inhalation

DRUG

single dose of 10 mcg

solution for inhalation

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01809262 on ClinicalTrials.gov