Cohort of IPF Patients Experiencing an Exacerbation

Sponsor

University Hospital, Gentofte, Copenhagen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04442711

Collaborator

(none)

Enrollment

Location

59.6

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Extension of the PFBIO cohort which includes patients with newly diagnosed idiopathic pulmonary fibrosis (IPF) for longitudinal follow-up for up to 5 years.

In the PFBIO-EXA extension, patients are included if they experience an exacerbation, or other increase in respiratory symptoms requiring hospital admission, for further collection of clinical and biological data.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis

Detailed Description

The aim of this study is to investigate the diagnostic and prognostic value of clinical and blood biomarkers during exacerbations, or other increase in respiratory symptoms requiring hospital admission in patients with IPF.

Patients that are already included in the PFBIO-cohort (NCT02755441) and who are admitted to hospital with an increase in respiratory symptoms, are also included in PFBIO-EXA.

Patients are recruited within 24 hrs. from hospital admission with respiratory worsening, where clinical data, and blood samples are collected. The blood samples are investigated for the same blood biomarkers as PFBIO.

Patient related outcomes are also collected, including quality-of-life questionnaires and outcomes of the exacerbations.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Pulmonary Fibrosis Biomarkers During Exacerbation

Actual Study Start Date :

Jun 13, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
PFBIO-EXA All patients recruited for PFBIO-EXA from the original PFBIO cohort are included into the cohort.

Outcome Measures

Primary Outcome Measures

Mortality [30 days]
All-cause mortality
Mortality [90 days]
All-cause mortality

Secondary Outcome Measures

Biomarker levels [30 days]
Blood biomarker level
LTOT [30 days]
Change in oxygen need
QoL [30 days]
Score of patient reported quality of life assessed by questionnaires
Respiratory support [30 days]
Need for non-invasive or invasive respiratory support, including oxygen, CPAP, NIV and intubation
Decline in functional level [30 days]
Decrease in functional level, e.g. moved to nursing home, hospice or other
Treatment during hospitalization [30 days]
Treatment administered for respiratory worsening
Treatment after hospitalization [90 days]
Treatment administered after discharge