Clinical trial NCT05492994: A Study to Test Different Imaging Techniques in Patients With Different Types of Interstitial Lung Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-08-09
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objectives of this imaging biomarker study are to assess the annual lung function change in patients with progressive fibrosing interstitial lung disease (PF-ILD) including idiopathic pulmonary fibrosis (IPF), with Usual Interstitial Pneumonia (UIP) or probable UIP Computer Tomography (CT) pattern, and to monitor lung structural changes.


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.

Primary outcomes:
measure: Absolute change in Forced Vital Capacity (FVC) % predicted from baseline to week 52
timeFrame: at baseline and at week 52
Secondary outcomes:
measure: Absolute change in fibrosis extent in % of lung volume determined on chest Computer Tomography (CT) from baseline to week 52
timeFrame: at baseline and at week 52
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
Study officials:
References: