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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
CIMS Studienzentrum Bamberg GmbH
Bamberg, Germany
Klinische Forschung Berlin GbR
Berlin, Germany
Universitätsklinikum Bonn AöR
Bonn, Germany
Praxis Dr. med. Claus Keller
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI) in the 6th Week of Treatment
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.
Time frame: Baseline and 6 weeks
Change From Baseline in Aortic Distensibility After 6 Weeks of Treatment
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.
Time frame: Baseline and 6 weeks
Change From Baseline in Pulmonary Artery Pulsatility After 6 Weeks of Treatment
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.
Time frame: Baseline and 6 weeks
Change From Baseline in Central Systolic Pressure After 6 Weeks of Treatment
Change from baseline in central systolic pressure is presented.
Time frame: Baseline and 6 weeks
Change From Baseline in Pulse Pressure After 6 Weeks of Treatment
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Fixed Dose Combination
Frankfurt, Germany
IKF Pneumologie GmbH & Co. KG
Frankfurt, 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
Change from baseline in pulse pressure is presented.
Time frame: Baseline and 6 weeks
Change From Baseline in Aortic Augmentation Index After 6 Weeks of Treatment
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.
Time frame: Baseline and 6 weeks
Change From Baseline in Functional Residual Capacity Body Plethysmography (FRCpleth) % Predicted After 6 Weeks of Treatment
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.
Time frame: Baseline and 6 weeks
Change From Baseline in 1.5 Hour Post Dose Forced Expiratory Volume in 1st Second (FEV1) After 6 Weeks of Treatment
Change from baseline in 1.5 hour post dose Forced Expiratory Volume in 1st second (FEV1) is presented.
Time frame: Baseline and 6 weeks
Change From Baseline in 1.5 Hour Post Dose Forced Vital Capacity (FVC) After 6 Weeks of Treatment
Change from baseline in 1.5 hour post dose Forced Vital Capacity (FVC) is presented.
Time frame: Baseline and 6 weeks