AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 4NCT03055988

Cardiovascular Function in COPD Patients

A Phase 4 study testing Tiotropium, Olodaterol and Fluticasone propionate in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 10 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Tiotropium, Olodaterol and Fluticasone propionate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
10 sitesGermany
Study dates
29 Mar 2017to 26 Mar 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must sign an informed consent consistent with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
  • All patients must have a diagnosis of chronic obstructive pulmonary disease for which they are treated with one or more long-acting inhaled bronchodilators prior to enrolment and must meet the following spirometric criteria:
  • Patients must have stable airway obstruction with a post-bronchodilator Forced Expiratory Volume in 1st second (FEV1) < 70% of predicted normal calculated with European Coal and Steel Community (ECSC) formulas, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC)< 70% at Visit 1
  • Patients with hyperinflation at rest defined as Functional Residual capacity (FRC) > 120 % predicted, with post-bronchodilator reversibility greater than and equal to 7,5 % predicted at Visit 1.
  • Male or female patients between 40 and 75 years of age (inclusive) on day of signing informed consent.
  • Patients with a smoking history of more than 10 pack years.
Show all 9Show fewer
  • Patients with Modified Medical Research Council (mMRC) Dyspnoea score > 1 at Visit 1.
  • Patients must be able to perform technically acceptable pulmonary function tests (spirometry and body plethysmography), Cardiac Magnetic Resonance (CMR), brachial blood pressure measurements with Pulse Wave Analysis (PWA) and other tests during the study period as required in the protocol.
  • Patients must be able to inhale medication in a competent manner from the Respimat and Accuhaler inhalers and from a metered dose inhaler (MDI).

Who cannot join

  • Patients with a significant disease other than Chronic Obstructive Pulmonary Disease (COPD).
  • Patients with a clinically relevant abnormal baseline haematology, blood chemistry, or creatinine.
  • Patients with a diagnosis of asthma.
  • Patients with a COPD exacerbation in the 6 weeks prior to screening (Visit 1) and patients who experience COPD exacerbation or respiratory tract infection during the washout phase prior to randomisation.
  • A history of myocardial infarction, cerebrovascular event or coronary artery intervention other than Coronary Artery Bypass Graft (CABG) within 1 year of screening.
  • Abnormal and clinically significant 12-lead Electrocardiogram (ECG).
Show all 27Show fewer
  • Hospitalized for heart failure within the past year. Current severe heart failure (New York Heart Association (NYHA) class IV. Ejection fraction <= 40% from Cardiac Magnetic Resonance (CMR) baseline assessment.
  • Patients with systolic blood pressure > 140mmHg and/or diastolic blood pressure > 90mmHg at Visit 1.
  • A diagnosis of thyrotoxicosis.
  • Known active tuberculosis, cardiac sarcoidosis.
  • Any malignancy unless free of disease for at least five years.
  • A history of cystic fibrosis.
  • Clinically evident bronchiectasis.
  • Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening.
  • A history of significant alcohol or drug abuse.
  • Patients who have undergone thoracotomy with pulmonary resection.
  • Patients being treated with any oral ß-adrenergics.
  • Patients being treated with oral corticosteroid medication within 6 weeks prior to Visit 1.
  • Patients being prescribed long-term home oxygen treatment.
  • Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.
  • Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit.
  • Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, fluticasone propionate or to any of the excipients, Benzalkonium chloride (BAC), Disodium edentate (EDTA) or Lactose monohydrate (which contains milk proteins) or any other component of the Respimat® or Accuhaler® delivery systems.
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • Women of childbearing potential not using highly effective methods of birth control.
  • Patients who have previously been enrolled in this study or are currently enrolled in another study.
  • Patient who are unable to comply with pulmonary medication restrictions prior to randomisation
  • Patients with pacemakers and metal implants (i.e. vascular clips and stents, metal silver in patient's eye) and patients with claustrophobia, due to contraindications for CMR.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • CIMS Studienzentrum Bamberg GmbH

    Bamberg, 96049

  • Klinische Forschung Berlin GbR

    Berlin, 10787

  • Universitätsklinikum Bonn AöR

    Bonn, 53105

  • Praxis Dr. med. Claus Keller

    Frankfurt, 60389

  • IKF Pneumologie GmbH & Co. KG

    Frankfurt, 60596

  • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927

  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • KLB Gesundheitsforschung Lübeck GmbH

    Lübeck, 23552

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • RoMed Kliniken

    Rosenheim, 83022

Other trials in Germany

About this study

Official title: An Exploratory, Randomised, Double-blind, Double-dummy, Active-controlled, Two Period Cross-over Study to Investigate the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (FDC) Delivered by the Respimat® Inhaler With Fluticasone Propionate + Salmeterol FDC Delivered by the Accuhaler® Inhaler, on Left Ventricular Function and Arterial Stiffness in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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.
Being tested
Tiotropium, Olodaterol, Fluticasone propionate, Salmeterol
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.

  • TiotropiumDrug

    Also called INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

    Fixed Dose Combination

  • OlodaterolDrug

    Also called INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

    Fixed Dose Combination

  • Fluticasone propionateDrug

    Fixed Dose Combination

  • SalmeterolDrug

    Fixed Dose Combination

Study groups in NCT03055988
Study groupRoleWhat they receive
Tiotropium/Olodaterol Fixed Dose CombinationExperimentalNot described
Receives: Drug: Tiotropium; Drug: Olodaterol
Fluticasone Propionate + Salmeterol Fixed Dose CombinationActive comparatorNot described
Receives: Drug: Fluticasone propionate; Drug: Salmeterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 6 weeks

Secondary outcomes (8)

  1. 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.

    Measured: Baseline and 6 weeks

  2. 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.

    Measured: Baseline and 6 weeks

  3. Change From Baseline in Central Systolic Pressure After 6 Weeks of Treatment

    Change from baseline in central systolic pressure is presented.

    Measured: Baseline and 6 weeks

  4. Change From Baseline in Pulse Pressure After 6 Weeks of Treatment

    Change from baseline in pulse pressure is presented.

    Measured: Baseline and 6 weeks

  5. 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.

    Measured: Baseline and 6 weeks

  6. 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.

    Measured: Baseline and 6 weeks

  7. 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.

    Measured: Baseline and 6 weeks

  8. 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.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2017
  2. Study start29 Mar 2017
  3. Primary completion5 Mar 2018
  4. Study completion26 Mar 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03055988
Sponsor's protocol ID
1237.36
Other IDs
2015-002641-66, 2015
Status last verified
Jul 2019
First submitted
14 Feb 2017
Last updated
16 Aug 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tiotropium, Olodaterol and Fluticasone propionate in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 10 sites 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 27 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: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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?

Yes. Results are posted in the registry (first posted 16 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI) in the 6th Week of Treatment (time frame: Baseline and 6 weeks). 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 NCT03055988.

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 16 Aug 2019; AzTrials last refreshed its copy on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in