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A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease

NCT01040728 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2014-06-30

Study results available
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Summary

The study is intended to characterize the lung function profile of BI1744 in Chronic Obstructive Pulmonary Disease (COPD) patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Olodaterol (BI1744) Low

Low dose inhaled orally once daily from Respimat inhaler

DRUG

Olodaterol (BI1744) High

High dose inhaled orally once daily from Respimat inhaler

DRUG

Tiotropium 18 mcg

18 mcg inhaled once daily from HandiHaler

DRUG

Placebo (for Olodaterol (BI1744)l)

Placebo (olodaterol low and high dose) delivered by Respimat

DRUG

Placebo (for Tiotropium)

Placebo (Tiotropium 18 mcg) delivered by HandiHaler

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
2011-01-31

Countries

  • United States
  • Germany
  • Netherlands
  • Norway

Study Locations

More Related Trials

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 NCT01040728 on ClinicalTrials.gov