Menu
Recruiting NCT05549635

Database and Biobank of Patients With Hypersensitivity Pneumonitis

Observational Hypersensitivity Pneumonitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hypersensitivity Pneumonitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Pulmonary Fibrosis Biobank - Hypersensitivity Pneumonitis

Overview

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.

Primary outcome measures

  • Diagnosis of HP [Time frame: 0 days]
  • Exposure to inciting antigen (patient reported) [Time frame: 0 days]
  • Exposure to inciting antigen (measurable) [Time frame: 0 days]
  • Progression free survival [Time frame: 3 years]
  • Overall survival [Time frame: 3 years]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Department of respiratory medicine — Hellerup

Identifiers

NCT: NCT05549635 · PFBIO-HP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗