Investigation of the Effects of Oxidized Antigens on the T-Cell Response and the Epigenetic Reprogramming of Neutrophils in Lung Diseases - OXIGENE -

NCT07386912 | Not Yet Recruiting

• 1 other identifier: OXIGENE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Asthma; COPD; Bacterial Pneumonia; Viral Pneumonia; Tuberculosis

Keywords

neutrophil granulocytes; epigenome; oxidation; antigens

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  2030

Secondary Outcomes (2)

• Influence of demographic and clinical variables

  2030

• Identification of subgroups within diseases

  2030

Study Arms (5)

Asthma

Patients with Asthma

Other: Characterization of the neutrophil granulocyte epigenome

COPD

Patients with chronic obstructive pulmonary disease

Other: Characterization of the neutrophil granulocyte epigenome

Viral pneumonia

Patients suffering from viral pneumonia, e.g. COVID-19 or Influenza

Other: Characterization of the neutrophil granulocyte epigenome

Bacterial pneumonia

Patients suffering from bacterial pneumonia

Other: Characterization of the neutrophil granulocyte epigenome

Tuberculosis

Patients treated for tuberculosis

Other: Characterization of the neutrophil granulocyte epigenome; Other: Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens

Interventions

Characterization of the neutrophil granulocyte epigenome OTHER

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

Asthma; Bacterial pneumonia; COPD; Tuberculosis; Viral pneumonia

Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens OTHER

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.

Tuberculosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Center Borstel: lead

Study Sites (2)

Medical Service Center MVZ, Research Center Borstel, Leibniz Lung Center

Borstel, Schleswig-Holstein, 23845, Germany

Location

Department of Pulmonology, University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Li-heparine plasma

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Pneumonia, Bacterial; Pneumonia, Viral; Tuberculosis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Virus Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections

Study Officials

• Jan Heyckendorf, Prof. Dr. med.

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Dallenga, Dr. rer. nat.

CONTACT

+49 4537 188 5561; tdallenga@fz-borstel.de

Niklas Koehler, Dr. med.

CONTACT

+49 4537 188 8080; studienzentrum@fz-borstel.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Jan Heyckendorf

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)