Cohort of IPF Patients Experiencing an Exacerbation

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis

• Registration Number: NCT04442711
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

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 Timeline

• Study Start: 2020-06-13
• Study First Submitted: 2020-06-13
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22
• Primary Completion: 2027-12-01
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Admitted with an increase in respiratory symptoms
• Already included in PFBIO or included simultaneously in PFBIO and PFBIO-EXA
• Age at least 18 years

Exclusion Criteria

• Unable to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	90 days	All-cause mortality

Secondary Outcome Measures

Name	Time	Method
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
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
Biomarker levels	30 days	Blood biomarker level
LTOT	30 days	Change in oxygen need
Treatment after hospitalization	90 days	Treatment administered after discharge

Trial Locations

Locations (1)

Herlev and Gentofte Hospital; 🇩🇰 Hellerup, Copenhagen, Denmark