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NCT Number: NCT04442711

Cohort of IPF Patients Experiencing an Exacerbation

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Disease Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herlev and Gentofte Hospital

Hellerup, Copenhagen, 2900, Denmark

Location status: Recruiting

Location contact

Nils Hoyer, MD PhD

CONTACT

[email protected]

+45 38674200

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 30 days

    All-cause mortality

  2. Mortality

    Time frame: 90 days

    All-cause mortality

Secondary outcomes

  1. Biomarker levels

    Time frame: 30 days

    Blood biomarker level

  2. LTOT

    Time frame: 30 days

    Change in oxygen need

  3. QoL

    Time frame: 30 days

    Score of patient reported quality of life assessed by questionnaires

  4. Respiratory support

    Time frame: 30 days

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

  5. Decline in functional level

    Time frame: 30 days

    Decrease in functional level, e.g. moved to nursing home, hospice or other

  6. Treatment during hospitalization

    Time frame: 30 days

    Treatment administered for respiratory worsening

  7. Treatment after hospitalization

    Time frame: 90 days

    Treatment administered after discharge

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Pulmonary Fibrosis Biomarkers During Exacerbation

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Jun 22, 2020
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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