Cohort of IPF Patients Experiencing an Exacerbation

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Pulmonary Fibrosis Biomarkers During Exacerbation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04442711
• Other study ID #: PFBIO-EXA
• Status: Recruiting
• Start date: June 13, 2020
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2028
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte Hospital	Hellerup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All-cause mortality	30 days
Primary	Mortality	All-cause mortality	90 days
Secondary	Biomarker levels	Blood biomarker level	30 days
Secondary	LTOT	Change in oxygen need	30 days
Secondary	QoL	Score of patient reported quality of life assessed by questionnaires	30 days
Secondary	Respiratory support	Need for non-invasive or invasive respiratory support, including oxygen, CPAP, NIV and intubation	30 days
Secondary	Decline in functional level	Decrease in functional level, e.g. moved to nursing home, hospice or other	30 days
Secondary	Treatment during hospitalization	Treatment administered for respiratory worsening	30 days
Secondary	Treatment after hospitalization	Treatment administered after discharge	90 days