Hypersensitivity PneumonitisPFBIO-HPNCT05549635
Database and Biobank of Patients With Hypersensitivity Pneumonitis
An observational study of Hypersensitivity Pneumonitis, run by Nils Hoyer at 1 site in Denmark.
Trial summary
Sub-study of the main Pulmonary Fibrosis Biomarker (PFBIO) cohort (NCT02755441), recruiting patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP). Patients are included for the collection of blood samples and regular clinical data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersensitivity Pneumonitis
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Sep 2022to 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
- Adult, Older adult
Study population: All adult patients with an MDT-diagnosis of HP are eligible.
Who may be able to join
- Diagnosis of HP at an MDT conference according to the current international guidelines
- Age of 18 years or older
- The patients must be capable of giving informed consent
Who cannot join
- Unable to sign 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
Department of respiratory medicine
Hellerup, Copenhagen, 2900
Nils Hoyer, PhD, +45 50589495, nils.hoyer@regionh.dk
About this study
Official title: Pulmonary Fibrosis Biobank - Hypersensitivity Pneumonitis
Sub-study of the main Pulmonary Fibrosis Biomarker (PFBIO) cohort (NCT02755441), recruiting patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP). Patients are included for the collection of blood samples and regular clinical data.
The database and biobank will be available for studies of HP, and can be directly compared to the main PFBIO cohort, which has recruited patients with Idiopathic pulmonary Fibrosis (IPF) since 2016.
Biomarkers will be assessed as diagnostic and prognostic. Further subtyping of HP, based on blood markers (including precipitins) will also be possible with the PFBIO-HP project.
- Conditions
- Hypersensitivity Pneumonitis
- Keywords
- biomarker, prognosis, diagnosis, phenotyping, genotyping
- Medical subject headings
- Alveolitis, Extrinsic Allergic, 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 |
|---|---|---|
| Patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP) | The overall inclusion criteria of patients in the HP cohort are: * Diagnosis of HP at an MDT conference according to the current international guidelines * Age of 18 years or older * The patients must be capable of giving informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of HP
MDT-Diagnosis of HP
Measured: 0 days
Exposure to inciting antigen (patient reported)
Known exposure, as reported by the patient
Measured: 0 days
Exposure to inciting antigen (measurable)
Measurable exposure, as tested by precipitins
Measured: 0 days
Progression free survival
Survival without progression
Measured: 3 years
Overall survival
Survival after diagnosis
Measured: 3 years
Secondary outcomes (4)
Quality of life questionnaires
SGRQ
Measured: 3 years
Pulmonary function test
FVC
Measured: 3 years
Pulmonary function test
DLCO
Measured: 3 years
Imaging
HRCT scans
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start18 Sep 2022
- Primary completion31 Dec 2024 (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 Hypersensitivity PneumonitisStudies 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
- Nils Hoyer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nils Hoyer, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549635
- Sponsor's protocol ID
- PFBIO-HP
- Acronym
- PFBIO-HP
- Status last verified
- Dec 2023
- First submitted
- 13 Jun 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 Biobank - Hypersensitivity Pneumonitis
- ClinicalTrials.gov ID
- NCT05549635
- Acronym / sponsor ID
- PFBIO-HP / PFBIO-HP
- Conditions
- Hypersensitivity Pneumonitis
- Keywords
- biomarker, prognosis, diagnosis, phenotyping, genotyping
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nils HoyerUniversity, hospital or other
- Study start
- 18 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Sep 2022 (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.
Sub-study of the main Pulmonary Fibrosis Biomarker (PFBIO) cohort (NCT02755441), recruiting patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP). Patients are included for the collection of blood samples and regular clinical data.
The database and biobank will be available for studies of HP, and can be directly compared to the main PFBIO cohort, which has recruited patients with Idiopathic pulmonary Fibrosis (IPF) since 2016.
Biomarkers will be assessed as diagnostic and prognostic. Further subtyping of HP, based on blood markers (including precipitins) will also be possible with the PFBIO-HP project.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP) | – | –The overall inclusion criteria of patients in the HP cohort are: * Diagnosis of HP at an MDT conference according to the current international guidelines * Age of 18 years or older * The patients must be capable of giving informed consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients with an MDT-diagnosis of HP are eligible.
Key inclusion criteria (3 listed)
- Diagnosis of HP at an MDT conference according to the current international guidelines
- Age of 18 years or older
- The patients must be capable of giving informed consent
Key exclusion criteria (1 listed)
- Unable to sign 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
Diagnosis of HP
Time frame: 0 days
MDT-Diagnosis of HP
Exposure to inciting antigen (patient reported)
Time frame: 0 days
Known exposure, as reported by the patient
Exposure to inciting antigen (measurable)
Time frame: 0 days
Measurable exposure, as tested by precipitins
Progression free survival
Time frame: 3 years
Survival without progression
Overall survival
Time frame: 3 years
Survival after diagnosis
4 secondary outcomes
Quality of life questionnaires
Time frame: 3 years
Pulmonary function test
Time frame: 3 years
Pulmonary function test
Time frame: 3 years
Imaging
Time frame: 3 years
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 Hypersensitivity Pneumonitis, run by Nils Hoyer 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?
Contact Nils Hoyer, PhD (+45-3867 4200, nils.hoyer@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of HP (time frame: 0 days). The study lists 5 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.