NCT02812862

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

June 14, 2016

Last Update Submit

October 25, 2022

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • To examine the change in Residual Volume (RV) V0-V2

    24 months

Secondary Outcomes (1)

  • To examine the change in trough FEV1

    24 months

Study Arms (1)

Treatment group

EXPERIMENTAL

20 male and female patients suffering from chronic heart failure and chronic obstructive pulmonary disease. Patients will be treated with Spiolto® Respimat® (the LABA/ LAMA combination)

Drug: Spiolto® Respimat® (Tiotropium / Olodaterol)

Interventions

Spiolto® Respimat® (Tiotropium / Olodaterol)DRUG

LABA/ LAMA combination therapy: A combination of two bronchodilators acting on two separate pharmacological targets - one ß-agonist and one anti-muscarinergic agent.

Also known as: Long-acting ß-agonist (LABA), Long-acting anti-muscarinergic agent (LAMA)
Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Lack of informed consent
  • Pregnant and lactating females
  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (2)

  • Bateman ED, Ferguson GT, Barnes N, Gallagher N, Green Y, Henley M, Banerji D. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J. 2013 Dec;42(6):1484-94. doi: 10.1183/09031936.00200212. Epub 2013 May 30.

    PMID: 23722616BACKGROUND

  • Dahl R, Chapman KR, Rudolf M, Mehta R, Kho P, Alagappan VK, Chen H, Banerji D. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med. 2013 Oct;107(10):1558-67. doi: 10.1016/j.rmed.2013.05.016. Epub 2013 Jul 16.

    PMID: 23867808BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromideolodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Michael Dreher, MD

    University Hospital, Aachen

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 24, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2018

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)