Idiopathic Pulmonary Fibrosis
Conditions
Keywords
Exacerbation, Hospitalization, Biomarkers, Outcome, Prognosis, Diagnosis
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.
Interventions
None listed
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | All-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Biomarker levels | 30 days | Blood biomarker level |
| Treatment during hospitalization | 30 days | Treatment administered for respiratory worsening |
| Treatment after hospitalization | 90 days | Treatment administered after discharge |
| Decline in functional level | 30 days | Decrease in functional level, e.g. moved to nursing home, hospice or other |
Countries
Denmark
Outcome results
None listed