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Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

NCT01431274 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2624

Last updated 2015-07-16

Study results available
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Summary

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

tiotropium + olodaterol

fixed dose combination

DRUG

tiotropium

low dose

DRUG

olodaterol

one dose only

DRUG

tiotropium

high dose

DRUG

tiotropium + olodaterol

fixed dose combination

DEVICE

Respimat

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
2011-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Guatemala
  • Hungary
  • India
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • New Zealand
  • Portugal
  • Russia
  • Slovenia
  • South Korea
  • Turkey (Türkiye)

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 NCT01431274 on ClinicalTrials.gov