Lung Diseases, InterstitialNCT05492994
A Study to Test Different Imaging Techniques in Patients With Different Types of Interstitial Lung Disease
A study testing Spirometry, Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) and Magnetic Resonance Imaging in people with Lung Diseases, Interstitial, run by Boehringer Ingelheim at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Lung Diseases, Interstitial
- What is being tested?
- Spirometry, Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) and Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- 19 Dec 2022to 17 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Lung Diseases, Interstitial
- Being tested
- Spirometry, Diffusing Capacity of the Lung for Carbon Monoxide (DLCO), Magnetic Resonance Imaging, Chest Computer Tomography, Blood biomarker analysis
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryDiagnostic test
Pulmonary function test
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)Diagnostic test
Pulmonary function test
Magnetic Resonance ImagingDiagnostic test
Magnetic Resonance Imaging
Chest Computer TomographyDiagnostic test
Chest Computer Tomography
Blood biomarker analysisDiagnostic test
Blood biomarker analysis
| Study group | Role | What they receive |
|---|---|---|
| Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) | Experimental | Not described Receives: Diagnostic Test: Spirometry; Diagnostic Test: Diffusing Capacity of the Lung for Carbon Monoxide (DLCO); Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Chest Computer Tomography; Diagnostic Test: Blood biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in Forced Vital Capacity (FVC) % predicted from baseline to week 52
Measured: 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
Measured: at baseline and at week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start19 Dec 2022
- Primary completion8 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492994
- Sponsor's protocol ID
- 0352-2157
- Status last verified
- Jun 2026
- First submitted
- 8 Aug 2022
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05492994
- Acronym / sponsor ID
- 0352-2157
- Conditions
- Lung Diseases, Interstitial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) | Experimental | Diagnostic Test: Spirometry, Diagnostic Test: Diffusing Capacity of the Lung for Carbon Monoxide (DLCO), Diagnostic Test: Magnetic Resonance Imaging, Diagnostic Test: Chest Computer Tomography, Diagnostic Test: Blood biomarker analysis |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpirometryPulmonary function test | Diagnostic test | Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) |
| Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)Pulmonary function test | Diagnostic test | Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) |
| Magnetic Resonance ImagingMagnetic Resonance Imaging | Diagnostic test | Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) |
| Chest Computer TomographyChest Computer Tomography | Diagnostic test | Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) |
| Blood biomarker analysisBlood biomarker analysis | Diagnostic test | Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) |
Primary outcome
Absolute change in Forced Vital Capacity (FVC) % predicted from baseline to week 52
Time frame: at baseline and at week 52
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry, Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) and Magnetic Resonance Imaging in people with Lung Diseases, Interstitial, run by Boehringer Ingelheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in Forced Vital Capacity (FVC) % predicted from baseline to week 52 (time frame: at baseline and at week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.