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Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)

NCT01040403 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2015-07-15

Study results available
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Summary

The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

olodaterol (BI 1744) low

olodaterol (BI 1744) low

DRUG

low tiotropium bromide

low tiotropium bromide

DRUG

olodaterol (BI 1744) high

olodaterol (BI 1744) high

DRUG

medium tiotropium bromide

medium tiotropium bromide

DRUG

high tiotropium bromide

high tiotropium bromide

DRUG

Placebo

Placebo

DEVICE

Respimat

Respimat inhaler

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
2010-01-31
Primary Completion
2011-02-28

Countries

  • Canada
  • Germany
  • Netherlands
  • Sweden

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 NCT01040403 on ClinicalTrials.gov