NCT06317428

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

3.5 years

First QC Date

March 12, 2024

Last Update Submit

March 12, 2024

Conditions

COPD

Keywords

COPDFormoterolglycopyrrolatebudesonideNT-pro-BNP

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Life expectancy less than one year;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

INRCA Hospital

Ancona, Italy

RECRUITING

IRCCS INRCA Hospital

Osimo, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Francesco Spannella

    IRCCS INRCA, Ancona, Italy

    STUDY CHAIR

Central Study Contacts

Anna Rita Bonfigli

CONTACT

0718003719a.bonfigli@inrca.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 19, 2024

Study Start

June 28, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations

IT(2)