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Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.

NCT01533935 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2015-09-15

Study results available
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Summary

The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Placebo

placebo matching tiotropium + olodaterol

DRUG

Tiotropium + Olodaterol

Tiotropium 2.5 mcg + olodaterol 5 mcg once daily

DRUG

tiotropium + Olodaterol

tiotropium 5 mcg + olodaterol 5 mcg once daily

DRUG

Tiotropium

tiotropium

DRUG

Olodaterol

Olodaterol 5 mcg once daily

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
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States
  • Argentina
  • Austria
  • Canada
  • Germany
  • Netherlands
  • Russia
  • Sweden

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 NCT01533935 on ClinicalTrials.gov