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12 / 48 Week Pivotal PFT vs PBO in COPD I

NCT00782210 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 625

Last updated 2014-06-09

Study results available
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Summary

This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).

The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Olodaterol (BI1744)

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

DRUG

Olodaterol (BI1744)

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

DRUG

placebo

Olodaterol (BI1744) placebo inhaled orally once daily from 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
2008-11-30
Primary Completion
2010-09-30

Countries

  • United States
  • Australia
  • China
  • Germany
  • New Zealand
  • Taiwan

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 NCT00782210 on ClinicalTrials.gov