Interstitial Lung DiseaseBREATH-TPTNCT07254338
Exploration of Metabolome in Patients With Interstitial Lung Disease and Pulmonary Hypertension With or Without Specific Pulmonary Hypertension Treatment
An observational study of Interstitial Lung Disease and Precapillar Pulmonary Hypertension, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Fibrosing interstitial lung diseases (FILDs) encompass a group of rare diseases characterized by progressive pulmonary fibrosis leading to respiratory failure. Current treatments primarily aim to slow disease progression but remain limited, making lung transplantation the ultimate recourse. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease, Precapillar Pulmonary Hypertension
- What is being tested?
- Blood sampling for metabolomic profiling and Urine sampling for metabolomic profiling
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2026to 16 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients monitored at Hospices Civils de Lyon for Interstitial Lung Disease, with suspected group 3 PH, for whom the medical team is considering or discussing the indication for specific ILD-PH treatment.
Who may be able to join
- Patients suffering from progressive interstitial lung disease (ILD) and especially lung fibrosis
- Suspicion of precapillar pulmonary hypertension (group 3 PH / ILD-PH)
- Patients undergoing cardiac catheterisation for haemodynamic confirmation
- Patient who has given informed consent
Who cannot join
- Patients suffering from other forms of PH (i.e. PAH, CTEPH, heart failure, multifactorial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Cardiologique et Pneumologique Louis Pradel
Bron, Rhone, 69500
Ségolène TURQUIER, 04 72 35 73 32 ext. +33, segolene.turquier@chu-lyon.fr
David LAVILLE, 04 27 85 51 39 ext. +33, david.laville@chu-lyon.fr
About this study
Official title: Blood and uRine Metabolomics Exploration for Assessing Thoracic Health After Treatment of Group 3 Pulmonary Hypertension
Fibrosing interstitial lung diseases (FILDs) encompass a group of rare diseases characterized by progressive pulmonary fibrosis leading to respiratory failure. Current treatments primarily aim to slow disease progression but remain limited, making lung transplantation the ultimate recourse.
The development of pulmonary hypertension (PH) in the context of FILDs significantly worsens morbidity and mortality and drastically reduces patients' life expectancy. Conventional treatments for PH are generally ineffective in this setting. Nevertheless, some promising therapeutic agents are currently under investigation, particularly inhaled prostacyclin analogs such as treprostinil, which have demonstrated efficacy in recent clinical studies.
Read more
Our study aims to explore, in a minimally invasive manner, variations in metabolites in the serum and urine of patients with PH secondary to FILDs, before and during treatment. The main objective is to better understand the systemic effect of these treatments. Furthermore, the identification of metabolomic signatures will allow us to differentiate responders from non-responders, thus providing valuable prognostic and predictive criteria.
To date, some patients do not benefit from the available treatments, and better selection of responders could prevent iatrogenic effects in patients whose clinical condition is already fragile. In addition, characterizing the systemic mode of action of these treatments could pave the way for new clinical research focused on the profiles of responding patients.
Finally, a thorough understanding of the efficacy of the studied therapies is essential. Indeed, effective treatment of PH in the context of FILDs could not only slow disease progression but also reduce the need for lung transplantation, a major challenge in a context of organ shortage.
- Being tested
- Blood sampling for metabolomic profiling, Urine sampling for metabolomic profiling
- Keywords
- ILD-PH, Inhaled Treprostinil, PH treatment, Metabolomic
- 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.
Blood sampling for metabolomic profilingOther
Blood (veinous) will be collected under standard care conditions, in a dry red blood tube without additional gel (4 mL) to obtain serum after centrifugation for 10 minutes at 1500g, in the form of 500µL aliquots, labelled with the patient's code in the study.
This sampling will be performed at baseline in both group; and after follow up completion in Group 1 (4-6 month)
Urine sampling for metabolomic profilingOther
Urine collected from patient into a dry powder compact in the waiting room before or after the consultation. Preparation of two cryotubes containing at least 1 mL per sample, labelled with the patient's code in the study. In the absence of a calling point, strict aseptic conditions are not required, as the use of chemicals or antiseptic soaps can interfere with the dosages.
This sampling will be performed in Group 1 and 2 at baseline; and in Group 1 at 2-month and after completion of follow-up time (4-6 month).
| Study group | Role | What they receive |
|---|---|---|
| Group "intervention" | Patients who suffer from ILD and ILD-PH from this group will be given specific treatments (especially inhaled TREPROSTINIL, up to 3 breath per use; 4 uses a day) for ILD-PH after usual independent collegial consultation Those patients will have before and after treatment blood and urine metabolomic profile.
They will have baseline and follow up blood and urine sampling. They will be offer possibility to perform up to 6 auto-sampling at home. Receives: Other: Blood sampling for metabolomic profiling; Other: Urine sampling for metabolomic profiling | |
| Group " control " | Patients who suffer from ILD and ILD-PH from this group will not be given specific ILD-PH treatment based on insufficient haemodynamic data or clinical contraindications after independent collegial consultation.
They will have only baseline blood and urine sampling. Receives: Other: Blood sampling for metabolomic profiling; Other: Urine sampling for metabolomic profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of urinary metabolite concentrations before and after initiation of treatment measured centrally by proton nuclear magnetic resonance spectroscopy (¹H-NMR).
The 1H-NMR analysis of each patient's urine will enable us to obtain a table showing the absolute concentration of metabolites per individual.
The effects of the drug response will be interpreted following pairwise-comparisons of metabolite concentrations per individual within Group 1, and expressed as fold change to perform a pathway assessment, notably using Metabo Analyst tool
Measured: Outcome is measured when all patients will have their 4-6 months follow-up completed.
Comparison of blood metabolite concentrations before and after initiation of treatment measured centrally by proton nuclear magnetic resonance spectroscopy (¹H-NMR).
The 1H-NMR analysis of each patient's blood will enable us to obtain a table showing the absolute concentration of metabolites per individual.
The effects of the drug response will be interpreted following pairwise-comparisons of metabolite concentrations per individual within Group 1, and expressed as fold change to perform a pathway assessment, notably using Metabo Analyst tool.
It will also allow us to explore kidney filtration effect on metabolic profile
Measured: Outcome is measured when all patients will have their 4-6 months follow-up completed.
Comparative prognosis analysis within sub-groups
Based on clinical response, several subgroups will be defined (responders, non-responders, paradoxical worsening) in order to define prognostic signatures using intergroup statistical comparisons of baseline metabolic concentrations.
Measured: Outcome is measured when all patients will have their 4-6 months follow-up completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start16 Feb 2026
- Primary completion16 Aug 2029 (estimated)
- Study completion16 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254338
- Sponsor's protocol ID
- 69HCL25_0216
- Acronym
- BREATH-TPT
- Status last verified
- Feb 2026
- First submitted
- 19 Nov 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood and uRine Metabolomics Exploration for Assessing Thoracic Health After Treatment of Group 3 Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07254338
- Acronym / sponsor ID
- BREATH-TPT / 69HCL25_0216
- Keywords
- ILD-PH, Inhaled Treprostinil, PH treatment, Metabolomic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 16 Aug 2029 (estimated)
- Study completion
- 16 Aug 2029 (estimated)
- First posted
- 28 Nov 2025 (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.
Fibrosing interstitial lung diseases (FILDs) encompass a group of rare diseases characterized by progressive pulmonary fibrosis leading to respiratory failure. Current treatments primarily aim to slow disease progression but remain limited, making lung transplantation the ultimate recourse.
The development of pulmonary hypertension (PH) in the context of FILDs significantly worsens morbidity and mortality and drastically reduces patients' life expectancy. Conventional treatments for PH are generally ineffective in this setting. Nevertheless, some promising therapeutic agents are currently under investigation, particularly inhaled prostacyclin analogs such as treprostinil, which have demonstrated efficacy in recent clinical studies.
Our study aims to explore, in a minimally invasive manner, variations in metabolites in the serum and urine of patients with PH secondary to FILDs, before and during treatment. The main objective is to better understand the systemic effect of these treatments. Furthermore, the identification of metabolomic signatures will allow us to differentiate responders from non-responders, thus providing valuable prognostic and predictive criteria.
To date, some patients do not benefit from the available treatments, and better selection of responders could prevent iatrogenic effects in patients whose clinical condition is already fragile. In addition, characterizing the systemic mode of action of these treatments could pave the way for new clinical research focused on the profiles of responding patients.
Finally, a thorough understanding of the efficacy of the studied therapies is essential. Indeed, effective treatment of PH in the context of FILDs could not only slow disease progression but also reduce the need for lung transplantation, a major challenge in a context of organ shortage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group "intervention" | – | Other: Blood sampling for metabolomic profiling, Other: Urine sampling for metabolomic profilingPatients who suffer from ILD and ILD-PH from this group will be given specific treatments (especially inhaled TREPROSTINIL, up to 3 breath per use; 4 uses a day) for ILD-PH after usual independent collegial consultation Those patients will have before and after treatment blood and urine metabolomic profile. They will have baseline and follow up blood and urine sampling. They will be offer possibility to perform up to 6 auto-sampling at home. |
| Group " control " | – | Other: Blood sampling for metabolomic profiling, Other: Urine sampling for metabolomic profilingPatients who suffer from ILD and ILD-PH from this group will not be given specific ILD-PH treatment based on insufficient haemodynamic data or clinical contraindications after independent collegial consultation. They will have only baseline blood and urine sampling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients monitored at Hospices Civils de Lyon for Interstitial Lung Disease, with suspected group 3 PH, for whom the medical team is considering or discussing the indication for specific ILD-PH treatment.
Key inclusion criteria (4 listed)
- Patients suffering from progressive interstitial lung disease (ILD) and especially lung fibrosis
- Suspicion of precapillar pulmonary hypertension (group 3 PH / ILD-PH)
- Patients undergoing cardiac catheterisation for haemodynamic confirmation
- Patient who has given informed consent
Key exclusion criteria (1 listed)
- Patients suffering from other forms of PH (i.e. PAH, CTEPH, heart failure, multifactorial
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 |
|---|---|---|
| Blood sampling for metabolomic profilingBlood (veinous) will be collected under standard care conditions, in a dry red blood tube without additional gel (4 mL) to obtain serum after centrifugation for 10 minutes at 1500g, in the form of 500µL aliquots, labelled with the patient's code in the study. This sampling will be performed at baseline in both group; and after follow up completion in Group 1 (4-6 month) | Other | Group " control ", Group "intervention" |
| Urine sampling for metabolomic profilingUrine collected from patient into a dry powder compact in the waiting room before or after the consultation. Preparation of two cryotubes containing at least 1 mL per sample, labelled with the patient's code in the study. In the absence of a calling point, strict aseptic conditions are not required, as the use of chemicals or antiseptic soaps can interfere with the dosages. This sampling will be performed in Group 1 and 2 at baseline; and in Group 1 at 2-month and after completion of follow-up time (4-6 month). | Other | Group " control ", Group "intervention" |
Primary outcome
Comparison of urinary metabolite concentrations before and after initiation of treatment measured centrally by proton nuclear magnetic resonance spectroscopy (¹H-NMR).
Time frame: Outcome is measured when all patients will have their 4-6 months follow-up completed.
The 1H-NMR analysis of each patient's urine will enable us to obtain a table showing the absolute concentration of metabolites per individual. The effects of the drug response will be interpreted following pairwise-comparisons of metabolite concentrations per individual within Group 1, and expressed as fold change to perform a pathway assessment, notably using Metabo Analyst tool
Comparison of blood metabolite concentrations before and after initiation of treatment measured centrally by proton nuclear magnetic resonance spectroscopy (¹H-NMR).
Time frame: Outcome is measured when all patients will have their 4-6 months follow-up completed.
The 1H-NMR analysis of each patient's blood will enable us to obtain a table showing the absolute concentration of metabolites per individual. The effects of the drug response will be interpreted following pairwise-comparisons of metabolite concentrations per individual within Group 1, and expressed as fold change to perform a pathway assessment, notably using Metabo Analyst tool. It will also allow us to explore kidney filtration effect on metabolic profile
Comparative prognosis analysis within sub-groups
Time frame: Outcome is measured when all patients will have their 4-6 months follow-up completed.
Based on clinical response, several subgroups will be defined (responders, non-responders, paradoxical worsening) in order to define prognostic signatures using intergroup statistical comparisons of baseline metabolic concentrations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Precapillar Pulmonary Hypertension, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Feb 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ségolène TURQUIER (04 72 35 73 32 ext. +33, segolene.turquier@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of urinary metabolite concentrations before and after initiation of treatment measured centrally by proton nuclear magnetic resonance spectroscopy (¹H-NMR). (time frame: Outcome is measured when all patients will have their 4-6 months follow-up completed.). The study lists 3 primary outcomes in all. 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 17 Feb 2026.