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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06317428
Other study ID # INRCA_001_2024
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 28, 2022
Est. completion date December 31, 2025

Study information

Verified date March 2024
Source Istituto Nazionale di Ricovero e Cura per Anziani
Contact Anna Rita Bonfigli
Phone 0718003719
Email a.bonfigli@inrca.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 29
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - COPD; - Clinical indication for triple inhalation therapy with formoterol/glycopyrrolate/budesonide; Exclusion Criteria: - Life expectancy less than one year;

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy INRCA Hospital Ancona
Italy IRCCS INRCA Hospital Osimo

Sponsors (1)

Lead Sponsor Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Before and 3 months after the start of triple therapy with formoterol/glycopyrrolate/budesonide
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