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A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPD

NCT01525615 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2016-08-29

Study results available
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Summary

The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DEVICE

Respimat inhaler

Respimat inhaler

DRUG

tiotropium+olodaterol (low dose)

2.5 µg tiotropium + 5 µg olodaterol

DRUG

tiotropium + olodaterol (high dose)

5 µg tiotropium + 5 µg olodaterol

DEVICE

Respimat inhaler

Respimat inhaler

DEVICE

Respimat inhaler

Respimat inhaler

DRUG

placebo to tiotropium+olodaterol

comparator

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States
  • Argentina
  • Canada
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Spain
  • United Kingdom

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 NCT01525615 on ClinicalTrials.gov