MedTrace Logo

Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.

NCT02296138 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7903

Last updated 2018-06-04

Study results available
· View outcomes & findings →

Summary

The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

olodaterol

fixed dose combination

DRUG

tiotropium

fixed dose combination

DRUG

tiotropium

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
2015-01-13
Primary Completion
2017-03-08
Completion
2017-03-29

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom
  • Vietnam

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 NCT02296138 on ClinicalTrials.gov