AsthmaOXIGENENCT07386912
Investigation of the Effects of Oxidized Antigens on the T-Cell Response and the Epigenetic Reprogramming of Neutrophils in Lung Diseases - OXIGENE -
An observational study of Asthma and COPD, run by Research Center Borstel at 2 sites in Germany.
Trial summary
The OXIGENE study is a research project that aims to better understand how the immune system behaves in people with lung diseases such as asthma, COPD, pneumonia, tuberculosis, and viral lung infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, COPD, Bacterial Pneumonia
- What is being tested?
- Characterization of the neutrophil granulocyte epigenome and Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Feb 2026to Dec 2030
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes only adult patients (≥18 years) with lung diseases who are capable of providing informed consent and are medically fit for a single venous blood draw. Minors, healthy volunteers, and adults lacking the capacity to consent are not included, as consent by legal representatives is not provided for, and the study involves no interventions beyond blood sampling. Women of childbearing potential may participate regardless of contraceptive use, as study participation poses no additional risk. Patients with insufficient German language proficiency may also be included; in such cases, study information is provided orally in a language the participant fully understands by a qualified translator, with the translation process documented, and written consent is given using the German-language consent form once full understanding has been ensured, allowing all participants to make an informed and voluntary decision.
Who may be able to join
- Diagnosis of an acute or chronic inflammatory lung disease, infectious or non-infectious, including asthma, COPD, pneumonia, tuberculosis, or viral pulmonary infection (e.g., COVID-19, influenza).
- Age ≥ 18 years at the time of informed consent.
- Ability to provide informed consent and consent to the collection and processing of clinical and laboratory data, as well as to the analysis of blood samples as part of study participation.
- Sufficient physical condition to undergo a single venous blood draw (approximately 50 mL), as assessed by the treating physician.
Who cannot join
- Active malignant disease or ongoing cancer therapy (e.g., chemotherapy or immunotherapy), due to potential immunological confounding.
- Immunosuppressive therapy or known severe immunodeficiency that could interfere with the interpretation of cellular immune responses.
- Pregnancy or breastfeeding, for general research-ethical reasons and to protect vulnerable populations.
- Acute unstable clinical condition that, in the opinion of the treating physician, makes study participation unreasonable.
- Known intolerance to blood sampling or relevant hematological disorders that could compromise the safety or feasibility of venipuncture.
- Lack of capacity to provide informed consent or insufficient understanding of the study content despite supportive explanation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites
Medical Service Center MVZ, Research Center Borstel, Leibniz Lung Center
Borstel, Schleswig-Holstein, 23845
Niklas Koehler, Dr. med., +49 4537 188 8080, studienzentrum@fz-borstel.de
Barbara Kalsdorf, PD Dr. med., +49 4537 188 3510, lungenpraxis@fz-borstel.de
Department of Pulmonology, University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
Jan Heyckendorf, Prof. Dr. med., +49 431 500-22223, Jan.Heyckendorf@uksh.de
Jan Heyckendorf, Prof. Dr. med.
About this study
The OXIGENE study is a research project that aims to better understand how the immune system behaves in people with lung diseases such as asthma, COPD, pneumonia, tuberculosis, and viral lung infections. By analyzing a single blood sample, the study examines how certain immune cells react during inflammation and infection, and whether lasting changes in these cells influence how strongly the body responds to disease. Although participants do not receive direct medical benefit, the results may help improve future diagnosis and treatment of lung diseases by providing deeper insight into immune responses.
Read the detailed description
The OXIGENE study is an observational research project that explores how the human immune system responds in different lung diseases, including asthma, COPD, pneumonia, tuberculosis, and viral lung infections such as COVID-19 or influenza. The study focuses on two key components of the immune system: neutrophils, which are among the first immune cells to respond to inflammation, and T cells, which play an important role in longer-term immune defense. Researchers investigate whether neutrophils show lasting changes in their behavior during lung disease and how these changes may differ depending on the type of illness or individual patient characteristics. In people with tuberculosis, the study also examines whether chemical changes to bacterial proteins caused by inflammation influence how strongly T cells are activated.
Participation in the study involves a single blood draw, similar to a routine blood test, with no medications, interventions, or follow-up visits required. The study does not provide direct medical benefit to participants, but the risks are minimal and limited to those associated with blood sampling. By improving the understanding of how immune responses are altered in lung diseases, the OXIGENE study aims to generate knowledge that could support the development of better diagnostic tools and more targeted treatments for future patients.
- Conditions
- Asthma, COPD, Bacterial Pneumonia, Viral Pneumonia, Tuberculosis
- Being tested
- Characterization of the neutrophil granulocyte epigenome, Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens
- Keywords
- neutrophil granulocytes, epigenome, oxidation, antigens
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Pneumonia, Bacterial, Pneumonia, Viral, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Characterization of the neutrophil granulocyte epigenomeOther
Characterization of epigenomic differences in neutrophils from patients with different lung diseases (asthma, COPD, pneumonia, tuberculosis, and viral pulmonary infections such as COVID-19 and influenza) by identifying disease-specific epigenetic and functional signatures
Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigensOther
Investigation of the response (activation/stimulation) of antigen-specific T cells from patients with tuberculosis to various oxidatively modified mycobacterial antigens, with the aim of determining whether changes in the redox status of these antigens measurably influence the adaptive immune response.
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Patients with Asthma Receives: Other: Characterization of the neutrophil granulocyte epigenome | |
| COPD | Patients with chronic obstructive pulmonary disease Receives: Other: Characterization of the neutrophil granulocyte epigenome | |
| Viral pneumonia | Patients suffering from viral pneumonia, e.g. COVID-19 or Influenza Receives: Other: Characterization of the neutrophil granulocyte epigenome | |
| Bacterial pneumonia | Patients suffering from bacterial pneumonia Receives: Other: Characterization of the neutrophil granulocyte epigenome | |
| Tuberculosis | Patients treated for tuberculosis Receives: Other: Characterization of the neutrophil granulocyte epigenome; Other: Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the neutrophil granulocyte epigenome
Stratification of patients with different lung diseases based on epigenetic signatures of neutrophils: Epigenetics: identification of disease-specific differences in DNA methylation patterns and transcriptional profiles (RNA sequencing).
Measured: 2030
Characterization of functional signatures
Stratification of patients with different lung diseases based on functional signatures of neutrophils:
Functional reactivity: quantitative assessment of reactive oxygen species production (oxidative burst) and cellular cell death (e.g., Sytox Green, Annexin V/PI) following stimulation with defined stimuli (e.g., PMA, LPS, Gram-positive/Gram-negative bacteria, BCG, Mycobacterium tuberculosis).
Measured: 2030
Secondary outcomes (2)
Influence of demographic and clinical variables
Correlation of demographic and clinical variables (age, sex, disease severity, medication, comorbidities) with epigenetic and functional parameters
Measured: 2030
Identification of subgroups within diseases
Exploratory identification of subgroups with characteristic or divergent profiles within the studied patient cohorts
Measured: 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center Borstel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Heyckendorf, University Hospital Schleswig-Holstein
- Investigators
- Jan Heyckendorf, Prof. Dr. med., Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386912
- Sponsor's protocol ID
- OXIGENE
- Acronym
- OXIGENE
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be shared upon reasonable request. Please contact the prinicpal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Oxidized Antigens on the T-Cell Response and the Epigenetic Reprogramming of Neutrophils in Lung Diseases - OXIGENE -
- ClinicalTrials.gov ID
- NCT07386912
- Acronym / sponsor ID
- OXIGENE / OXIGENE
- Conditions
- Asthma, COPD, Bacterial Pneumonia, Viral Pneumonia, Tuberculosis
- Keywords
- neutrophil granulocytes, epigenome, oxidation, antigens
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Research Center BorstelUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Feb 2026 (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 OXIGENE study is a research project that aims to better understand how the immune system behaves in people with lung diseases such as asthma, COPD, pneumonia, tuberculosis, and viral lung infections. By analyzing a single blood sample, the study examines how certain immune cells react during inflammation and infection, and whether lasting changes in these cells influence how strongly the body responds to disease. Although participants do not receive direct medical benefit, the results may help improve future diagnosis and treatment of lung diseases by providing deeper insight into immune responses.
Detailed description
The OXIGENE study is an observational research project that explores how the human immune system responds in different lung diseases, including asthma, COPD, pneumonia, tuberculosis, and viral lung infections such as COVID-19 or influenza. The study focuses on two key components of the immune system: neutrophils, which are among the first immune cells to respond to inflammation, and T cells, which play an important role in longer-term immune defense. Researchers investigate whether neutrophils show lasting changes in their behavior during lung disease and how these changes may differ depending on the type of illness or individual patient characteristics. In people with tuberculosis, the study also examines whether chemical changes to bacterial proteins caused by inflammation influence how strongly T cells are activated.
Participation in the study involves a single blood draw, similar to a routine blood test, with no medications, interventions, or follow-up visits required. The study does not provide direct medical benefit to participants, but the risks are minimal and limited to those associated with blood sampling. By improving the understanding of how immune responses are altered in lung diseases, the OXIGENE study aims to generate knowledge that could support the development of better diagnostic tools and more targeted treatments for future patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Other: Characterization of the neutrophil granulocyte epigenomePatients with Asthma |
| COPD | – | Other: Characterization of the neutrophil granulocyte epigenomePatients with chronic obstructive pulmonary disease |
| Viral pneumonia | – | Other: Characterization of the neutrophil granulocyte epigenomePatients suffering from viral pneumonia, e.g. COVID-19 or Influenza |
| Bacterial pneumonia | – | Other: Characterization of the neutrophil granulocyte epigenomePatients suffering from bacterial pneumonia |
| Tuberculosis | – | Other: Characterization of the neutrophil granulocyte epigenome, Other: Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigensPatients treated for tuberculosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes only adult patients (≥18 years) with lung diseases who are capable of providing informed consent and are medically fit for a single venous blood draw. Minors, healthy volunteers, and adults lacking the capacity to consent are not included, as consent by legal representatives is not provided for, and the study involves no interventions beyond blood sampling. Women of childbearing potential may participate regardless of contraceptive use, as study participation poses no additional risk. Patients with insufficient German language proficiency may also be included; in such cases, study information is provided orally in a language the participant fully understands by a qualified translator, with the translation process documented, and written consent is given using the German-language consent form once full understanding has been ensured, allowing all participants to make an informed and voluntary decision.
Key inclusion criteria (4 listed)
- Diagnosis of an acute or chronic inflammatory lung disease, infectious or non-infectious, including asthma, COPD, pneumonia, tuberculosis, or viral pulmonary infection (e.g., COVID-19, influenza).
- Age ≥ 18 years at the time of informed consent.
- Ability to provide informed consent and consent to the collection and processing of clinical and laboratory data, as well as to the analysis of blood samples as part of study participation.
- Sufficient physical condition to undergo a single venous blood draw (approximately 50 mL), as assessed by the treating physician.
Key exclusion criteria (6 listed)
- Active malignant disease or ongoing cancer therapy (e.g., chemotherapy or immunotherapy), due to potential immunological confounding.
- Immunosuppressive therapy or known severe immunodeficiency that could interfere with the interpretation of cellular immune responses.
- Pregnancy or breastfeeding, for general research-ethical reasons and to protect vulnerable populations.
- Acute unstable clinical condition that, in the opinion of the treating physician, makes study participation unreasonable.
- Known intolerance to blood sampling or relevant hematological disorders that could compromise the safety or feasibility of venipuncture.
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 |
|---|---|---|
| Characterization of the neutrophil granulocyte epigenomeCharacterization of epigenomic differences in neutrophils from patients with different lung diseases (asthma, COPD, pneumonia, tuberculosis, and viral pulmonary infections such as COVID-19 and influenza) by identifying disease-specific epigenetic and functional signatures | Other | Asthma, Bacterial pneumonia, COPD, Tuberculosis, Viral pneumonia |
| Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigensInvestigation of the response (activation/stimulation) of antigen-specific T cells from patients with tuberculosis to various oxidatively modified mycobacterial antigens, with the aim of determining whether changes in the redox status of these antigens measurably influence the adaptive immune response. | Other | Tuberculosis |
Primary outcome
Characterization of the neutrophil granulocyte epigenome
Time frame: 2030
Stratification of patients with different lung diseases based on epigenetic signatures of neutrophils: Epigenetics: identification of disease-specific differences in DNA methylation patterns and transcriptional profiles (RNA sequencing).
Characterization of functional signatures
Time frame: 2030
Stratification of patients with different lung diseases based on functional signatures of neutrophils: Functional reactivity: quantitative assessment of reactive oxygen species production (oxidative burst) and cellular cell death (e.g., Sytox Green, Annexin V/PI) following stimulation with defined stimuli (e.g., PMA, LPS, Gram-positive/Gram-negative bacteria, BCG, Mycobacterium tuberculosis).
2 secondary outcomes
Influence of demographic and clinical variables
Time frame: 2030
Identification of subgroups within diseases
Time frame: 2030
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 4 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will be shared upon reasonable request. Please contact the prinicpal investigator.
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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.
Jan Heyckendorf, Prof. Dr. med. principal investigator
University Hospital Schleswig-Holstein
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and COPD, run by Research Center Borstel at 2 sites 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 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 2 sites 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?
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 Tobias Dallenga, Dr. rer. nat. (+49 4537 188 5561, tdallenga@fz-borstel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the neutrophil granulocyte epigenome (time frame: 2030). The study lists 2 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 4 Feb 2026.