COPDPhase 4CREATESNCT02812862
Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD
A Phase 4 study testing Spiolto® Respimat® (Tiotropium / Olodaterol) in people with COPD, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Spiolto® Respimat® (Tiotropium / Olodaterol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic of Cardiology, Angiology, Pneumology and Intensive Medicine, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
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.
- Conditions
- COPD
- Being tested
- Spiolto® Respimat® (Tiotropium / Olodaterol)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiolto® Respimat® (Tiotropium / Olodaterol)Drug
Also called Long-acting ß-agonist (LABA), Long-acting anti-muscarinergic agent (LAMA)
LABA/ LAMA combination therapy:
A combination of two bronchodilators acting on two separate pharmacological targets - one ß-agonist and one anti-muscarinergic agent.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Spiolto® Respimat® (Tiotropium / Olodaterol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the change in Residual Volume (RV) V0-V2
Measured: 24 months
Secondary outcomes (1)
To examine the change in trough FEV1
Time Points: values at V0 compared with V2
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: Rationale obsolete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Dreher, MD, Principal investigator, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812862
- Sponsor's protocol ID
- 15-165
- Acronym
- CREATES
- Status last verified
- Oct 2022
- First submitted
- 14 Jun 2016
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23722616Dahl 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.
PubMed 23867808
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD
- ClinicalTrials.gov ID
- NCT02812862
- Acronym / sponsor ID
- CREATES / 15-165
- Conditions
- COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Rationale obsolete
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Spiolto® Respimat® (Tiotropium / Olodaterol)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiolto® Respimat® (Tiotropium / Olodaterol)Also: Long-acting ß-agonist (LABA), Long-acting anti-muscarinergic agent (LAMA)LABA/ LAMA combination therapy: A combination of two bronchodilators acting on two separate pharmacological targets - one ß-agonist and one anti-muscarinergic agent. | Drug | Treatment group |
Primary outcome
To examine the change in Residual Volume (RV) V0-V2
Time frame: 24 months
1 secondary outcome
To examine the change in trough FEV1
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Background: PubMed 23722616Bateman 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.
- Background: PubMed 23867808Dahl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Dreher, MD principal investigator
University Hospital, Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spiolto® Respimat® (Tiotropium / Olodaterol) in people with COPD, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the change in Residual Volume (RV) V0-V2 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02812862, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.