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

Research Center Borstel

Status: Not yet enrolling

Conditions: Asthma; Tuberculosis; Bacterial Pneumonia; Viral Pneumonia; COPD

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

Study type: Observational

Funder types: Other

Identifiers

NCT07386912

OXIGENE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

100 participants in 5 patient groups

Asthma

Description:

Patients with Asthma

Treatment:

Other: Characterization of the neutrophil granulocyte epigenome

COPD

Description:

Patients with chronic obstructive pulmonary disease

Treatment:

Other: Characterization of the neutrophil granulocyte epigenome

Viral pneumonia

Description:

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

Treatment:

Other: Characterization of the neutrophil granulocyte epigenome

Bacterial pneumonia

Description:

Patients suffering from bacterial pneumonia

Treatment:

Other: Characterization of the neutrophil granulocyte epigenome

Tuberculosis

Description:

Patients treated for tuberculosis

Treatment:

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

Other: Characterization of the neutrophil granulocyte epigenome