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Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease

NCT01559116 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2015-07-16

Study results available
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Summary

The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

tiotropium + olodaterol

low dose + one dose only

DRUG

tiotropium

low dose

DRUG

olodaterol

one dose only

DRUG

tiotropium

high dose

DRUG

tiotropium + olodaterol

low dose + one dose only

DRUG

Placebo

placebo matching tiotropium+olodaterol FDC

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
2012-03-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States
  • Belgium
  • Canada
  • Denmark
  • Germany
  • Hungary
  • Netherlands

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 NCT01559116 on ClinicalTrials.gov