Learn about Research & Clinical Trials

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05492994
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lung Diseases, Interstitial
Study Website: View Trial Website
Arms & Interventions

Arms

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

Interventions

Diagnostic Test: - Spirometry

Pulmonary function test

Diagnostic Test: - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

Pulmonary function test

Diagnostic Test: - Magnetic Resonance Imaging

Magnetic Resonance Imaging

Diagnostic Test: - Chest Computer Tomography

Chest Computer Tomography

Diagnostic Test: - Blood biomarker analysis

Blood biomarker analysis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Medizinische Hochschule Hannover, Hannover, Germany

Status

Recruiting

Address

Medizinische Hochschule Hannover

Hannover, , 30625

Site Contact

Boehringer Ingelheim

[email protected]

08007234742