Cardiovascular Function in COPD Patients

NCT03055988 | Completed Phase 4 Results

• 2 other identifiers: 1237.362015-002641-66
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 10

Brief 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 assessed by CMR and pulse wave analysis (PWA),
• reduction of hyperinflation assessed with body plethysmography and
• post dose spirometry.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (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.

  Baseline and 6 weeks

Secondary Outcomes (8)

• Change From Baseline in Aortic Distensibility After 6 Weeks of Treatment

  Baseline and 6 weeks

• Change From Baseline in Pulmonary Artery Pulsatility After 6 Weeks of Treatment

  Baseline and 6 weeks

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

  Baseline and 6 weeks

• Change From Baseline in Pulse Pressure After 6 Weeks of Treatment

  Baseline and 6 weeks

• Change From Baseline in Aortic Augmentation Index After 6 Weeks of Treatment

  Baseline and 6 weeks

Study Arms (2)

Tiotropium/Olodaterol Fixed Dose Combination

EXPERIMENTAL

Drug: Tiotropium; Drug: Olodaterol

Fluticasone Propionate + Salmeterol Fixed Dose Combination

ACTIVE COMPARATOR

Drug: Fluticasone propionate; Drug: Salmeterol

Interventions

Tiotropium DRUG

Fixed Dose Combination

Also known as: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

Tiotropium/Olodaterol Fixed Dose Combination

Olodaterol DRUG

Fixed Dose Combination

Also known as: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

Tiotropium/Olodaterol Fixed Dose Combination

Fluticasone propionate DRUG

Fixed Dose Combination

Fluticasone Propionate + Salmeterol Fixed Dose Combination

Salmeterol DRUG

Fixed Dose Combination

Fluticasone Propionate + Salmeterol Fixed Dose Combination

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (10)

CIMS Studienzentrum Bamberg GmbH

Bamberg, 96049, Germany

Location

Klinische Forschung Berlin GbR

Berlin, 10787, Germany

Location

Universitätsklinikum Bonn AöR

Bonn, 53105, Germany

Location

Praxis Dr. med. Claus Keller

Frankfurt, 60389, Germany

Location

IKF Pneumologie GmbH & Co. KG

Frankfurt, 60596, Germany

Location

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany

Location

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

KLB Gesundheitsforschung Lübeck GmbH

Lübeck, 23552, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

RoMed Kliniken

Rosenheim, 83022, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; olodaterol; Fluticasone; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: March 29, 2017
• Primary Completion: March 5, 2018
• Study Completion: March 26, 2018
• Last Updated: August 16, 2019
• Results First Posted: August 16, 2019

Record last verified: 2019-07

Locations

DE (10)