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

March 12, 2024 updated by: Istituto Nazionale di Ricovero e Cura per Anziani

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy
        • Recruiting
        • INRCA Hospital
        • Contact:
        • Principal Investigator:
          • Riccardo Sarzani, MD
      • Osimo, Italy
        • Recruiting
        • IRCCS INRCA Hospital
        • Contact:
        • Principal Investigator:
          • Yuri Rosati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Life expectancy less than one year;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before and 3 months after the start of triple therapy with formoterol/glycopyrrolate/budesonide

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Investigators

  • Study Chair: Francesco Spannella, IRCCS INRCA, Ancona, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INRCA_001_2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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