P4O2 ILD Extension

Plain-language summary

This observational study aims to follow people with interstitial lung disease (ILD, a group of conditions that cause scarring of lung tissue) over the long term. Patients aged 18-80 with various fibrotic lung diseases, such as idiopathic pulmonary fibrosis, can take part. It is a study without an assigned phase and is still enrolling participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Amsterdam UMC, location VUmc

Intervention

No Interventions

Start date

11/1/2024

Estimated completion

10/1/2031

Countries

Netherlands

Related genes

Locations

• Amsterdam, Netherlands

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Diagnosis of (1) idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), (2) other fibrotic ILDs (fILD), including fibrotic hypersensitivity pneumonitis (fHP), idiopathic non-specific interstitial pneumonia (iNSIP), connective tissue disease (CTD)-ILD, and unclassifiable ILD (uILD); or (3) interstitial lung abnormalities (ILA).
* Meeting all the following criteria during the screening period:

  1. FVC ≥45% predicted.
  2. FEV1/FVC ≥0.7.
  3. DLco corrected for Hb ≥40% predicted.
* Able to provide written informed consent as approved by the independent ethics committee.
* Able to undergo a CT scan and perform PFT.
* Age \> 18 years and \< 80 years.
* Understanding of the Dutch or English language.

Exclusion Criteria:

* Combined pulmonary fibrosis and emphysema (CPFE) diagnosis
* Chronic obstructive lung disease (COPD) with an FEV1/FVC \<70%.
* Uncontrolled severe asthma.
* Active malignancy, except for squamous cell carcinoma of the skin, low-risk breast cancer, and low-risk prostate cancer.
* Pregnancy or lactating.