NCT05492994

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Dec 2022Jun 2026

First Submitted

Initial submission to the registry

August 8, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 19, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2026

Last Updated

August 5, 2025

Status Verified

August 1, 2025

Enrollment Period

3.5 years

First QC Date

August 8, 2022

Last Update Submit

August 4, 2025

Conditions

Lung Diseases, Interstitial

Outcome Measures

Primary Outcomes (1)

  • Absolute change in Forced Vital Capacity (FVC) % predicted from baseline to week 52

    at baseline and at week 52

Secondary Outcomes (1)

  • Absolute change in fibrosis extent in % of lung volume determined on chest Computer Tomography (CT) from baseline to week 52

    at baseline and at week 52

Study Arms (1)

Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

EXPERIMENTAL
Diagnostic Test: SpirometryDiagnostic Test: Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)Diagnostic Test: Magnetic Resonance ImagingDiagnostic Test: Chest Computer TomographyDiagnostic Test: Blood biomarker analysis

Interventions

SpirometryDIAGNOSTIC_TEST

Pulmonary function test

Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)DIAGNOSTIC_TEST

Pulmonary function test

Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Magnetic Resonance ImagingDIAGNOSTIC_TEST

Magnetic Resonance Imaging

Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Chest Computer TomographyDIAGNOSTIC_TEST

Chest Computer Tomography

Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Blood biomarker analysisDIAGNOSTIC_TEST

Blood biomarker analysis

Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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))
  • Male or female patients aged ≥ 40 years when signing the informed consent.
  • Forced Vital Capacity (FVC) ≥ 45% predicted of normal reviewed at Visit 1.
  • Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) corrected for Haemoglobin ≥ 25% of predicted normal reviewed at Visit 1.
  • Body mass index (BMI) \<=30 kg/m2 reviewed at Visit 1.
  • Glomerular filtration rate (GFR) ≥30 ml/min reviewed at Visit 1.
  • 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.

You may not qualify if:

  • 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).
  • Any documented active or suspected malignancy or history of malignancy on discretion of the investigator.
  • 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.
  • 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).
  • Previous enrolment in this study.
  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Related Links

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

SpirometryMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisTomographyDiagnostic Imaging

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 9, 2022

Study Start

December 19, 2022

Primary Completion (Estimated)

June 9, 2026

Study Completion (Estimated)

June 9, 2026

Last Updated

August 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Locations

DE(1)