Idiopathic Pulmonary FibrosisNCT04442711
Cohort of IPF Patients Experiencing an Exacerbation
An observational study of Idiopathic Pulmonary Fibrosis, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Jun 2020to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients already included in PFBIO that are admitted with a respiratory worsening are eligible for inclusion.
Who may be able to join
- Admitted with an increase in respiratory symptoms
- Already included in PFBIO or included simultaneously in PFBIO and PFBIO-EXA
- Age at least 18 years
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Herlev and Gentofte Hospital
Hellerup, Copenhagen, 2900
Nils Hoyer, MD PhD, +45 38674200, nils.hoyer@regionh.dk
About this study
Official title: Pulmonary Fibrosis Biomarkers During 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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Exacerbation, Hospitalization, Biomarkers, Outcome, Prognosis, Diagnosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PFBIO-EXA | All patients recruited for PFBIO-EXA from the original PFBIO cohort are included into the cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause mortality
Measured: 30 days
Mortality
All-cause mortality
Measured: 90 days
Secondary outcomes (7)
Biomarker levels
Blood biomarker level
Measured: 30 days
LTOT
Change in oxygen need
Measured: 30 days
QoL
Score of patient reported quality of life assessed by questionnaires
Measured: 30 days
Respiratory support
Need for non-invasive or invasive respiratory support, including oxygen, CPAP, NIV and intubation
Measured: 30 days
Decline in functional level
Decrease in functional level, e.g. moved to nursing home, hospice or other
Measured: 30 days
Treatment during hospitalization
Treatment administered for respiratory worsening
Measured: 30 days
Treatment after hospitalization
Treatment administered after discharge
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start13 Jun 2020
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nils Hoyer, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442711
- Sponsor's protocol ID
- PFBIO-EXA
- Status last verified
- Dec 2023
- First submitted
- 13 Jun 2020
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Fibrosis Biomarkers During Exacerbation
- ClinicalTrials.gov ID
- NCT04442711
- Acronym / sponsor ID
- PFBIO-EXA
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Exacerbation, Hospitalization, Biomarkers, Outcome, Prognosis, Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 13 Jun 2020 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PFBIO-EXA | – | –All patients recruited for PFBIO-EXA from the original PFBIO cohort are included into the cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients already included in PFBIO that are admitted with a respiratory worsening are eligible for inclusion.
Key inclusion criteria (3 listed)
- Admitted with an increase in respiratory symptoms
- Already included in PFBIO or included simultaneously in PFBIO and PFBIO-EXA
- Age at least 18 years
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 30 days
All-cause mortality
Mortality
Time frame: 90 days
All-cause mortality
7 secondary outcomes
Biomarker levels
Time frame: 30 days
LTOT
Time frame: 30 days
QoL
Time frame: 30 days
Respiratory support
Time frame: 30 days
Decline in functional level
Time frame: 30 days
Treatment during hospitalization
Time frame: 30 days
Treatment after hospitalization
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.