MedTrace Logo

Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I

NCT00793624 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 906

Last updated 2014-06-27

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Olodaterol (BI 1744)

Comparison of low and high doses on efficacy and safety in COPD patients

DRUG

Olodaterol (BI 1744)

Comparison of low and high doses on efficacy and safety in COPD patients

DRUG

Formoterol

Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients

DRUG

Placebo

Placebo for comparison with Olodaterol (BI 1744) on safety and efficacy in COPD patients

DRUG

Placebo

Placebo for comparison Formoterolon safety and efficacy in COPD patients

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
2009-02-28
Primary Completion
2010-12-31

Countries

  • Argentina
  • Brazil
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Hong Kong
  • India
  • Italy
  • Malaysia
  • Norway
  • Philippines
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Thailand
  • Ukraine

Study Locations

More Related Trials

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 NCT00793624 on ClinicalTrials.gov