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Cohort of IPF Patients Experiencing an Exacerbation

ConditionIdiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Gentofte, Copenhagen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admitted with an increase in respiratory symptoms

Already included in PFBIO or included simultaneously in PFBIO and PFBIO-EXA

Age at least 18 years

Disqualifiers

Unable to provide informed consent

Trial population

Patients already included in PFBIO that are admitted with a respiratory worsening are eligible for inclusion.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: PFBIO-EXA

Trial outcomes

Primary outcomes

1

Mortality

All-cause mortality

Time frame
30 days
2

Mortality

All-cause mortality

Time frame
90 days

Secondary outcomes

1

Biomarker levels

Blood biomarker level

Time frame
30 days
2

LTOT

Change in oxygen need

Time frame
30 days
3

QoL

Score of patient reported quality of life assessed by questionnaires

Time frame
30 days
4

Respiratory support

Need for non-invasive or invasive respiratory support, including oxygen, CPAP, NIV and intubation

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Gentofte, Copenhagen

Lead sponsor

Source ClinicalTrials.gov
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