Database and Biobank of Patients With Hypersensitivity Pneumonitis

Hypersensitivity Pneumonitis Clinical Trial

— PFBIO-HP  

Official title:

Pulmonary Fibrosis Biobank - Hypersensitivity Pneumonitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05549635
• Other study ID #: PFBIO-HP
• Status: Recruiting
• Start date: September 18, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Nils Hoyer, PhD
• Phone: +45-3867 4200
• Email: nils.hoyer[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Unable to sign informed consent

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Hypersensitivity
• Hypersensitivity Pneumonitis
• Pneumonia

Locations

Country	Name	City	State
Denmark	Department of respiratory medicine	Hellerup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Nils Hoyer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of HP	MDT-Diagnosis of HP	0 days
Primary	Exposure to inciting antigen (patient reported)	Known exposure, as reported by the patient	0 days
Primary	Exposure to inciting antigen (measurable)	Measurable exposure, as tested by precipitins	0 days
Primary	Progression free survival	Survival without progression	3 years
Primary	Overall survival	Survival after diagnosis	3 years
Secondary	Quality of life questionnaires	SGRQ	3 years
Secondary	Pulmonary function test	FVC	3 years
Secondary	Pulmonary function test	DLCO	3 years
Secondary	Imaging	HRCT scans	3 years