NCT03055988

Cardiovascular Function in COPD Patients

An Exploratory, Randomised, Double-blind, Double-dummy, Active-controlled, Two Period Cross-over Study to Investigate the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (FDC) Delivered by the Respimat® Inhaler With Fluticasone Propionate + Salmeterol FDC Delivered by the Accuhaler® Inhaler, on Left Ventricular Function and Arterial Stiffness in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Tiotropium	Fixed Dose Combination
DRUG	Olodaterol	Fixed Dose Combination
DRUG	Fluticasone propionate	Fixed Dose Combination
DRUG	Salmeterol	Fixed Dose Combination

Timeline

• Start date: 2017-03-29
• Primary completion: 2018-03-05
• Completion: 2018-03-26
• First posted: 2017-02-16
• Last updated: 2019-08-16
• Results posted: 2019-08-16

Locations

10 sites across 1 country: Germany