A Study to Test Different Imaging Techniques in Patients With Different Types of Interstitial Lung Disease
NCT ID: NCT05492994
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
31 participants
INTERVENTIONAL
2022-12-19
2026-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Spirometry
Pulmonary function test
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Pulmonary function test
Magnetic Resonance Imaging
Magnetic Resonance Imaging
Chest Computer Tomography
Chest Computer Tomography
Blood biomarker analysis
Blood biomarker analysis
Interventions
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Spirometry
Pulmonary function test
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Pulmonary function test
Magnetic Resonance Imaging
Magnetic Resonance Imaging
Chest Computer Tomography
Chest Computer Tomography
Blood biomarker analysis
Blood biomarker analysis
Eligibility Criteria
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Inclusion Criteria
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
* 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.
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Medizinische Hochschule Hannover
Hanover, , Germany
Countries
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Related Links
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Related Info
Related Info
Other Identifiers
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0352-2157
Identifier Type: -
Identifier Source: org_study_id
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