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Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Japanese Patients With COPD

NCT00824382 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2014-06-27

Study results available
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Summary

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

BI 1744 CL 2 µg

2 puffs of 1 µg/actuation delivered by the Respimat® inhaler

DRUG

BI 1744 CL 5 µg

2 puffs of 2.5 µg/actuation delivered by the Respimat® inhaler

DRUG

BI 1744 CL 10 µg

2 puffs of 5 µg/actuation delivered by Respimat®

DRUG

Placebo

2 puffs delivered by the Respimat® inhaler

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-03-31

Countries

  • Japan

Study Locations

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Entities

Drugs
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 NCT00824382 on ClinicalTrials.gov