COPD
Conditions
Brief summary
The aim of this study is to evaluate the pulmonary and cardiac effects of the LABA / LAMA combination Tiotropium / Olodaterol therapy in patients suffering from both congestive heart failure and chronic obstructive pulmonary disease.
Interventions
DRUGSpiolto® Respimat® (Tiotropium / Olodaterol)
LABA/ LAMA combination therapy: A combination of two bronchodilators acting on two separate pharmacological targets - one ß-agonist and one anti-muscarinergic agent.
Sponsors
RWTH Aachen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel * Symptomatic with regard to dyspnea (NYHA II-III, mMRC Dyspnea score \> 1) * Diagnosis of COPD (FEV1/FVC ratio \<70%, FEV1 \< 80%) * Patients with hyperinflation at rest defined as Residual Volume (RV) \> 135 % predicted * Diagnosis of moderate symptomatic ischaemic Congestive heart failure (LVEF \> 35 -45%) * Stability of CHF during the preceding 3 months (no hospitalization due to CHF, stable CHF medication) * Male or female aged \> 18 years * Written informed consent prior to study participation * The subject is willing and able to follow the procedures outlined in the protocol
Exclusion criteria
* Lack of informed consent * Pregnant and lactating females * Acute moderate-severe exacerbation of COPD, acute respiratory failure (pH \< 7,35 and/ or respiratory rate \> 30/min within 3 months prior to inclusion) * Unstable heart failure or planned change in medication (hospitalization due to CHF within 3 months prior to inclusion), any angina pectoris * Not symptomatic * Patient has been committed to an institution by legal or regulatory order * Participation in a parallel interventional clinical trial * Any COPD maintenance therapy before start of randomization * History or diagnosis of Asthma * LVEF \<35 % or ICD or pacemaker * Myocardial infarction 6 months prior inclusion * History of life-threatening arrhythmias (e.g. NSVT or ventricular tachycardia, aFib, AV-Block, pacemaker treatment etc.) * History of diagnosis of Thyrotoxicosis * Chronic kidney disease with an crea-clearance ≤30 ml/min * History of significant alcohol or drug abuse, as judged by the Investigator * Fibrotic lung disease (e.g. IPF, ILD) * Contraindications for MRT (e.g. pacemaker, defibrillator, ferromagnetic metal implants, tattoos, claustrophobia, etc. according to MRI checklist used in the clinical routine)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine the change in Residual Volume (RV) V0-V2 | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To examine the change in trough FEV1 | 24 months | Time Points: values at V0 compared with V2 |
Countries
Germany
Outcome results
None listed