COPDNTproBNPNCT06317428

NT-proBNP Levels During Triple Therapy With Formoterol/Glycopyrrolate/Budesonide in Patients With COPD.

An observational study of COPD, run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Observational prospective study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the iniation of triple inhaled formoterol/glycopyrrolate/budesonide therapy. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: COPD
How many people: 29 participants
Where: 2 sitesItaly
Study dates: 28 Jun 2022to 31 Dec 2025
Phase: Observational
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects with COPD with clinical indication for triple inhalation therapy with formoterol/glycopyrrolate/budesonide;

Who may be able to join

COPD;
Clinical indication for triple inhalation therapy with formoterol/glycopyrrolate/budesonide;

Who cannot join

Life expectancy less than one year;

Trial locations and contacts

2 sites in 1 country.

Anna Rita Bonfigli contact

0718003719

a.bonfigli@inrca.it

Italy2 sites, 2 recruiting

INRCA Hospital
Ancona
Francesco Spannella, f.spannella@inrca.it
Riccardo Sarzani, MD
Recruiting
IRCCS INRCA Hospital
Osimo
Erilda Kamberi, MD, e.kamberi@inrca.it
Yuri Rosati
Recruiting

Other trials in Italy

About this study

Official title: Change in Serum Levels of NT-proBNP During Triple Therapy With Formoterol/Glycopyrrolate/Budesonide in Patients With COPD.

Observational prospective study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the iniation of triple inhaled formoterol/glycopyrrolate/budesonide therapy.

Read the detailed description

The purpose of the trixeo study is to conduct a prospective observational study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the initiation of triple inhaled formoterol/glycopyrrolate/budesonide therapy.

Conditions: COPD
Keywords: COPD, Formoterol, glycopyrrolate, budesonide, NT-pro-BNP
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What is being measured

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

Change in serum NT-pro-BNP levels
Before and 3 months after the introduction of bronchodilator therapy with formoterol/glycopyrrolate/budesonide, patients will be evaluated to assess serum NT-proBNP levels.
Measured: Before and 3 months after the start of triple therapy with formoterol/glycopyrrolate/budesonide

Timeline

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

28 Jun 202231 Dec 2025

First posted19 Mar 2024
Study start28 Jun 2022
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 29 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06317428
Sponsor's protocol ID: INRCA_001_2024
Acronym: NTproBNP
Status last verified: Mar 2024
First submitted: 12 Mar 2024
Last updated: 19 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Anna Rita Bonfigli

0718003719

a.bonfigli@inrca.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Change in Serum Levels of NT-proBNP During Triple Therapy With Formoterol/Glycopyrrolate/Budesonide in Patients With COPD.
ClinicalTrials.gov ID: NCT06317428
Acronym / sponsor ID: NTproBNP / INRCA_001_2024
Conditions: COPD
Keywords: COPD, Formoterol, glycopyrrolate, budesonide, NT-pro-BNP
Study type: Observational
Recruitment status: Unknown status
Enrolment: 29 participants (estimated)
Lead sponsor: Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
Study start: 28 Jun 2022 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 19 Mar 2024 (actual)
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.

Observational prospective study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the iniation of triple inhaled formoterol/glycopyrrolate/budesonide therapy.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects with COPD with clinical indication for triple inhalation therapy with formoterol/glycopyrrolate/budesonide;

Key inclusion criteria (2 listed)

COPD;
Clinical indication for triple inhalation therapy with formoterol/glycopyrrolate/budesonide;

Key exclusion criteria (1 listed)

Life expectancy less than one year;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change in serum NT-pro-BNP levels
Time frame: Before and 3 months after the start of triple therapy with formoterol/glycopyrrolate/budesonide
Before and 3 months after the introduction of bronchodilator therapy with formoterol/glycopyrrolate/budesonide, patients will be evaluated to assess serum NT-proBNP levels.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

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.

Anna Rita Bonfigli contact

0718003719

a.bonfigli@inrca.it

Francesco Spannella study chair

IRCCS INRCA, Ancona, Italy

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COPD, run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites in Italy.

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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anna Rita Bonfigli (0718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum NT-pro-BNP levels (time frame: Before and 3 months after the start of triple therapy with formoterol/glycopyrrolate/budesonide). 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 NCT06317428.

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 19 Mar 2024.