Cardiovascular Function in COPD Patients

Phase 4

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Fluticasone propionate; Drug: Tiotropium; Drug: Salmeterol; Drug: Olodaterol

• Registration Number: NCT03055988
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-14
• Study First Posted: 2017-02-16
• Study Start: 2017-03-29
• Primary Completion: 2018-03-05
• Study Completion: 2018-03-26
• Results First Submitted: 2019-03-20
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Results First Posted: 2019-08-16
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fluticasone Propionate + Salmeterol Fixed Dose Combination	Fluticasone propionate	-
Fluticasone Propionate + Salmeterol Fixed Dose Combination	Salmeterol	-
Tiotropium/Olodaterol Fixed Dose Combination	Tiotropium	-
Tiotropium/Olodaterol Fixed Dose Combination	Olodaterol	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI) in the 6th Week of Treatment	Baseline and 6 weeks	LVEDVI is normalised left ventricular end diastolic volume, divided by body surface area.; Baseline was defined as the value obtained during the assessment performed in a week prior to Visit 2 (Day 1). The change from baseline was calculated as the value obtained in a week prior to Visits 3 and 4 (end of each treatment periods) minus the baseline value.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Aortic Distensibility After 6 Weeks of Treatment	Baseline and 6 weeks	Change from baseline in aortic distensibility is presented. Aortic distensibility measurements as measure of arterial stiffness were derived from cine images acquired at end-expiration in planes perpendicular to the thoracic aorta at the level of the pulmonary artery (ascending and descending section of thoracic aorta), abdominal aorta, and perpendicularly to the main, right, and left pulmonary arteries.
Change From Baseline in 1.5 Hour Post Dose Forced Vital Capacity (FVC) After 6 Weeks of Treatment	Baseline and 6 weeks	Change from baseline in 1.5 hour post dose Forced Vital Capacity (FVC) is presented.
Change From Baseline in Functional Residual Capacity Body Plethysmography (FRCpleth) % Predicted After 6 Weeks of Treatment	Baseline and 6 weeks	Change from Baseline in Functional Residual Capacity Body Plethysmography (FRCpleth) % predicted is presented. Functional residual capacity, percent predicted is a lung volume at the end of normal expiration assessed/measured by body plethysmography and compared to predicted capacity for such subject, if nonsmoker and without a disease which could compromise their ventilator function, to give a percentage predicted.
Change From Baseline in Central Systolic Pressure After 6 Weeks of Treatment	Baseline and 6 weeks	Change from baseline in central systolic pressure is presented.
Change From Baseline in Pulse Pressure After 6 Weeks of Treatment	Baseline and 6 weeks	Change from baseline in pulse pressure is presented.
Change From Baseline in Aortic Augmentation Index After 6 Weeks of Treatment	Baseline and 6 weeks	Change from baseline in aortic augmentation index is presented. Augmentation index was derived from brachial pulse wave separation analysis as augmentation pressure (pressure difference between the reflection wave to the ejection wave) divided by central pulse pressure (at the central aortic site) multiplied by 100.
Change From Baseline in Pulmonary Artery Pulsatility After 6 Weeks of Treatment	Baseline and 6 weeks	Change from baseline in pulmonary artery pulsatility (PAP) is presented. Pulmonary artery pulsatility measurements as measure of arterial stiffness were derived from cine images acquired at end-expiration in planes perpendicular to the thoracic aorta at the level of the pulmonary artery (ascending and descending section of thoracic aorta), abdominal aorta, and perpendicularly to the main, right, and left pulmonary arteries.
Change From Baseline in 1.5 Hour Post Dose Forced Expiratory Volume in 1st Second (FEV1) After 6 Weeks of Treatment	Baseline and 6 weeks	Change from baseline in 1.5 hour post dose Forced Expiratory Volume in 1st second (FEV1) is presented.

Trial Locations

Locations (10)

Universitätsklinikum Bonn AöR; 🇩🇪 Bonn, Germany

Klinische Forschung Berlin GbR; 🇩🇪 Berlin, Germany

Praxis Dr. med. Claus Keller; 🇩🇪 Frankfurt, Germany

CIMS Studienzentrum Bamberg GmbH; 🇩🇪 Bamberg, Germany

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH; 🇩🇪 Großhansdorf, Germany

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

KLB Gesundheitsforschung Lübeck GmbH; 🇩🇪 Lübeck, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz; 🇩🇪 Mainz, Germany

RoMed Kliniken; 🇩🇪 Rosenheim, Germany

IKF Pneumologie GmbH & Co. KG; 🇩🇪 Frankfurt, Germany