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A Study to Test Different Imaging Techniques in Patients With Different Types of Interstitial Lung Disease

Primary Purpose

Lung Diseases, Interstitial

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Spirometry
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Magnetic Resonance Imaging
Chest Computer Tomography
Blood biomarker analysis
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Diseases, Interstitial

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 documented Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2) infection will be excluded if happened 6 months before screening.
  • 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.

    8. Life expectancy for disease other than Interstitial Lung Disease (ILD) <2.5 years (investigator assessment) Further exclusion criteria apply.

Sites / Locations

  • Medizinische Hochschule HannoverRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 8, 2022
Last Updated
July 27, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05492994
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
April 22, 2025 (Anticipated)
Study Completion Date
April 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Spirometry
Intervention Description
Pulmonary function test
Intervention Type
Diagnostic Test
Intervention Name(s)
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Intervention Description
Pulmonary function test
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
Magnetic Resonance Imaging
Intervention Type
Diagnostic Test
Intervention Name(s)
Chest Computer Tomography
Intervention Description
Chest Computer Tomography
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood biomarker analysis
Intervention Description
Blood biomarker analysis
Primary Outcome Measure Information:
Title
Absolute change in Forced Vital Capacity (FVC) % predicted from baseline to week 52
Time Frame
at baseline and at week 52
Secondary Outcome Measure Information:
Title
Absolute change in fibrosis extent in % of lung volume determined on chest Computer Tomography (CT) from baseline to week 52
Time Frame
at baseline and at week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Life expectancy for disease other than Interstitial Lung Disease (ILD) <2.5 years (investigator assessment) Further exclusion criteria apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
Facility Information:
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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
Links:
URL
https://www.mystudywindow.com
Description
Related Info
URL
https://mhh-jvc.de/team
Description
Related Info

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A Study to Test Different Imaging Techniques in Patients With Different Types of Interstitial Lung Disease

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