Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFBIO-EXA | All patients recruited for PFBIO-EXA from the original PFBIO cohort are included into the cohort. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All-cause mortality | 30 days |
| Mortality | All-cause mortality | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker levels | Blood biomarker level | 30 days |
| LTOT | Change in oxygen need | 30 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients already included in PFBIO that are admitted with a respiratory worsening are eligible for inclusion.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte Hospital | Recruiting | Hellerup | Copenhagen | 2900 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood serum and plasma are collected within 24 hrs of hospital admission for measurement of biomarkers.
| QoL | Score of patient reported quality of life assessed by questionnaires | 30 days |
| Respiratory support | Need for non-invasive or invasive respiratory support, including oxygen, CPAP, NIV and intubation | 30 days |
| Decline in functional level | Decrease in functional level, e.g. moved to nursing home, hospice or other | 30 days |
| Treatment during hospitalization | Treatment administered for respiratory worsening | 30 days |
| Treatment after hospitalization | Treatment administered after discharge | 90 days |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |