Effect of dual bronchodilation with umeclidinium/vilanterol on patients with COPD, hyperinflation and heart failure

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital General Universitario Gregorio Maranon

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

20 Nov 2024 → ongoing

Decision date (initial)

2024-11-20

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-519513-61-00

EudraCT number

2019-004427-20

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To address the effect of treatment with umeclidinium/vilanterol 55/22 μg compared to placebo on the increase in stroke volume during exercise in patients with COPD

Secondary objectives 3

1. To address the effect of umeclidinium+vilanterol 55/22 mcg compared to placebo on the reduction of dynamic hyperinflation (relative to baseline)
2. To address the effect of umeclidinium+vilanterol 55/22 mcg compared to placebo on resting cardiac function (relative to baseline)
3. To address the effect of umeclidinium/vilanterol 55/22 μg compared to placebo on the symptoms reported by the patient (relative to baseline)

Conditions and MedDRA coding

Chronic obstructive pulmonary diseases with Heart Failure with eyection ventricular ejection fraction between 35-50%

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients aged at least 40 years with a clinical diagnosis of COPD
2. Airflow limitation indicated by a screening post-bronchodilator FEV1 of less than 80% predicted and a post-bronchodilator FEV1 to forced vital capacity (FVC) ratio of less than 0.7
3. Smoking history of at least ten pack-years
4. Baseline lung hyperinflation with a residual volume of more than 135% predicted
5. Stable heart failure
6. Left ventricle ejection fraction in the range of 35% to 55%
7. A suitable ultrasonic window from the apical view

Exclusion criteria 8

1. Do not sign the informed consent
2. Unstable cardiovascular diseases
3. Atrial fibrillation or other arrhythmias requiring treatment
4. Unstable ischemic heart disease
5. Uncontrolled hypertension
6. Patients unable to undergo cardiac MR scanning (claustrophobia or carrying non MR-compatible devices)
7. Patients unable to perform exercise test (locomotor conditions)
8. Inadequate ultrasound window from the apical view

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Baseline-corrected, time-velocity integral (a direct surrogate of SV) during peak exercise, as measured by exercise Doppler-echocardiography (last satisfactory measurement)
2. Maximal oxygen pulse on a cardiopulmonary exercise test on cycle-ergometer

Secondary endpoints 9

1. Resting lung volumes ( Inspiratory capacity, functional residual capacity and residual volume)
2. Inspiratory Capacity every 2 minutes during the incremental exercise test
3. Left and right cardiac chambers volumes at rest in patients, as measured by MRI
4. Baseline-corrected peak ejection intraventricular pressure difference (peak EIVPD) at peak exercise, as measured by exercise color-Doppler M-mode echocardiography (last satisfactory measurement)
5. Pulmonary acceleration time in the main pulmonary artery as measured by phase-contrast MRI
6. Baseline-corrected peak intraventricular diastolic pressure gradient (peak DIVPD) at peak exercise – diastolic suction, as measured by exercise color-Doppler M-mode echocardiography (last satisfactory measurement)
7. ProBNP levels
8. Average changes in COPD Assessment Test (CAT) and Transition dyspnea index
9. Proportion of patients with Clinically relevant changes in COPD Assessment Test (CAT) and Transition dyspnea index ( -4 and -2 respectively)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital General Universitario Gregorio Maranon

Sponsor organisation

Hospital General Universitario Gregorio Maranon

Address

Calle Del Doctor Esquerdo 46

City

Madrid

Postcode

28007

Country

Spain

Scientific contact point

Organisation

Hospital General Universitario Gregorio Maranon

Contact name

Servicio de Neumología

Public contact point

Organisation

Hospital General Universitario Gregorio Maranon

Contact name

Servicio de Neumología

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications