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NCT Number: NCT05549635

Database and Biobank of Patients With 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.

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Key information

Conditions

Hypersensitivity Pneumonitis Alveolitis, Extrinsic Allergic Disease Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of respiratory medicine

Hellerup, Copenhagen, 2900, Denmark

Location status: Recruiting

Location contact

Nils Hoyer, PhD

CONTACT

[email protected]

+45 50589495

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnosis of HP

    Time frame: 0 days

    MDT-Diagnosis of HP

  2. Exposure to inciting antigen (patient reported)

    Time frame: 0 days

    Known exposure, as reported by the patient

  3. Exposure to inciting antigen (measurable)

    Time frame: 0 days

    Measurable exposure, as tested by precipitins

  4. Progression free survival

    Time frame: 3 years

    Survival without progression

  5. Overall survival

    Time frame: 3 years

    Survival after diagnosis

Secondary outcomes

  1. Quality of life questionnaires

    Time frame: 3 years

    SGRQ

  2. Pulmonary function test

    Time frame: 3 years

    FVC

  3. Pulmonary function test

    Time frame: 3 years

    DLCO

  4. Imaging

    Time frame: 3 years

    HRCT scans

Study contacts

Contact information is provided by the study sponsor or research team.

Nils Hoyer, PhD

CONTACT

[email protected]

+45-3867 4200

Sponsors and collaborators

Lead sponsor

Nils Hoyer

Other

Registry information

Official study title

Pulmonary Fibrosis Biobank - Hypersensitivity Pneumonitis

Acronym: PFBIO-HP

Important dates

Study start
2022
Primary completion
2024
Study completion
2028
First posted
Sep 22, 2022
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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