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To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways

NCT02085161 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2017-01-06

Study results available
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Summary

The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

placebo to tiotropium + olodaterol

comparator

DRUG

tiotropium+olodaterol

tiotropium 5 mcg once daily

DRUG

tiotropium +olodaterol

olodaterol 5 mcg once daily fixed dose combination

DRUG

tiotropium

tiotropium 5 mcg once daily fixed dose combination

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-08-31
Completion
2015-10-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • Germany
  • New Zealand
  • Poland
  • Portugal
  • 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 NCT02085161 on ClinicalTrials.gov