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Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients

NCT02853123 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2019-09-27

Study results available
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Summary

The primary objective of the present study is to evaluate the effect of tiotropium + olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity of breathlessness during the 3min constant speed shuttle test (CSST).

A secondary objective is to explore the relationship between reductions in breathlessness during the 3min CSST and reductions in breathlessness during activities of everyday living as measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following bronchodilator therapy.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Tiotropium

fixed dose combination once daily

DRUG

Olodaterol

fixed dose combination once daily

DRUG

Tiotropium

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
2016-09-22
Primary Completion
2017-07-24
Completion
2017-08-14

Countries

  • Belgium
  • Canada
  • Germany
  • Netherlands

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 NCT02853123 on ClinicalTrials.gov