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Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)

NCT01964352 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 813

Last updated 2015-11-25

Study results available
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Summary

The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

tiotropium

fixed dose combination

DRUG

placebo

DRUG

olodaterol

fixed dose combination

DRUG

tiotropium

fixed dose combination

DRUG

tiotropium

DRUG

olodaterol

fixed dose combination

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
2013-11-30
Primary Completion
2014-10-31
Completion
2014-11-30

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • Germany
  • South Africa
  • Spain
  • United Kingdom

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 NCT01964352 on ClinicalTrials.gov