Testing imaging techniques for patients with interstitial lung disease

Longitudinal Study Without an Investigational Medicinal Product in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) to Evaluate Novel Imaging-based Biomarkers in Comparison With Lung Function for Use in Early Clinical Development

This study is testing different imaging methods to see how they can help track lung changes in people with progressive fibrosing interstitial lung disease who haven't started treatment yet.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 1 site (Hannover)
• Trial ID: NCT05492994 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate various imaging methods to monitor lung function changes in patients diagnosed with progressive fibrosing interstitial lung disease (PF-ILD), including idiopathic pulmonary fibrosis (IPF). Participants will undergo assessments such as spirometry, diffusing capacity tests, magnetic resonance imaging, and chest CT scans to track lung structural changes over time. The study focuses on treatment-naive patients to establish baseline data without the influence of anti-fibrotic medications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with a documented diagnosis of PF-ILD and specific lung function criteria.

Not a fit: Patients currently receiving anti-fibrotic treatment or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and monitoring techniques for patients with interstitial lung disease.

How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for lung diseases, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the study.
2. Patients with a documented diagnosis of Progressive Fibrosing Interstitial Lung Disease (PF-ILD) including Idiopathic Pulmonary Fibrosis (IPF), with Usual Interstitial Pneumonia (UIP) or probable UIP chest Computer Tomography (CT) pattern and no anti-fibrotic treatment (nintedanib or pirfenidone) at baseline and previously (treatment-naive regarding Standard of Care (SoC))
3. Male or female patients aged ≥ 40 years when signing the informed consent.
4. Forced Vital Capacity (FVC) ≥ 45% predicted of normal reviewed at Visit 1.
5. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) corrected for Haemoglobin ≥ 25% of predicted normal reviewed at Visit 1.
6. Body mass index (BMI) \<=30 kg/m2 reviewed at Visit 1.
7. Glomerular filtration rate (GFR) ≥30 ml/min reviewed at Visit 1.
8. Supportive Thyroid-Stimulating Hormone (TSH) evaluation for all participants \>60 years and/or history of thyroid disease according to local standard procedures at Visit 1.

Exclusion Criteria:

1. Significant pulmonary disease other than PF-ILD or other medical conditions (as determined by medical history, examination and clinical investigations at screening) that may, in the opinion of the investigator result in any of the following:

   * Put the patient at risk because of participation in the study
   * Influence the results of the study
   * Cause concern regarding the patient's ability to participate in the study Patients with a history of a documented Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection will be excluded if lung changes due to the infection have been observed at screening (on discretion of the investigator).
2. Any documented active or suspected malignancy or history of malignancy on discretion of the investigator.
3. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the accurate assessment of endpoints of the study.
4. Patients not able to understand or follow study procedures or patients not expected to comply with the protocol requirements or not expected to complete the study as scheduled (e.g., chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable study participant).
5. Previous enrolment in this study.
6. Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s).
7. Women who are pregnant, nursing, or who plan to become pregnant while in the study. Women of childbearing potential1 not willing or able to use highly effective methods of birth control per International Council for Harmonisation (ICH) M3 (R2). A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol.
8. Life expectancy for disease other than Interstitial Lung Disease (ILD) \<2.5 years (investigator assessment) Further exclusion criteria apply.

Where this trial is running

Hannover

• Medizinische Hochschule Hannover — Hannover, Germany (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Lung Diseases, Interstitial