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Cardiovascular Function in COPD Patients

NCT03055988 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2019-08-16

Study results available
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Summary

The objectives of the study are to explore the effect of treatment with tiotropium + olodaterol fixed dose combination (FDC) compared to fluticasone propionate + salmeterol FDC on:

* reversal of left ventricular diastolic dysfunction assessed with cardiac magnetic resonance (CMR) imaging,
* measures of arterial stiffness assessed by CMR and pulse wave analysis (PWA),
* reduction of hyperinflation assessed with body plethysmography and
* post dose spirometry.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Tiotropium

Fixed Dose Combination

DRUG

Olodaterol

Fixed Dose Combination

DRUG

Fluticasone propionate

Fixed Dose Combination

DRUG

Salmeterol

Fixed Dose Combination

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
2017-03-29
Primary Completion
2018-03-05
Completion
2018-03-26

Countries

  • Germany

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 NCT03055988 on ClinicalTrials.gov