Characterization of Natural Killer Cells in Severe Asthma Patients in Comparison With Control Subjects
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood sample.
- Who it may be relevant to
- Registry conditions: Asthma Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterization of Natural Killer Cells in Severe Asthma Patients in Comparison With Control Subjects: Identification of Biomarkers, Response During Virus-induced Exacerbations, and Interaction With Bronchial Epithelial Cells
Overview
Asthma is a common chronic bronchial disease affecting 300 million people worldwide. The disease can be severe when it is not managed properly or when it is not controlled by treatments. Asthma is characterized by bronchial inflammation, bronchial hyperreactivity and tissue remodeling. Symptoms include episodes of coughing, dyspnoea and wheezing in relation with bronchial obstruction. The evolution is marked by the occurrence of exacerbations (increase of symptoms), most often triggered by viral infections, mostly due to rhinoviruses. The treatment of asthma is based on inhaled corticosteroid therapy sometimes combined with other treatments that help control the majority of asthma. However, about 10% of patients suffer from persistent symptoms despite these treatments. Natural killer (NK) cells are important actors of the antiviral innate immune response and are present in high numbers in the lungs. However, their role in severe asthma and its virus-induced exacerbations is unknown. The purpose of this work is to characterize NK cells in severe asthma in order to identify molecules expressed differently from control subjects. The goal is to assess whether these molecules could be potential biomarkers of a severe asthma subtype, also known as the endotype, and/or be the molecular control for exacerbation. The advantage of identifying biomarkers for inflammatory diseases lies in their usefulness in establishing a correct diagnosis, monitoring the progress of the disease and the effectiveness of treatments. The secondary objectives are to characterize the activation of NK cells in response to in vitro rhinovirus infection of different types, in monoculture or in a model of interaction with a bronchial epithelium, and identify one or more molecules involved in the interaction between bronchial epithelial cells and NK cells.
Interventions
- Biological blood sample
Blood sample (56mL) taken in a heparin tube
Primary outcome measures
- Changes in expression of one or more molecules on the surface of NK cells [Time frame: day 1 to day 2555]
Secondary outcome measures (2)
- Measurement of NK cell activation [Time frame: day 1 to day 2555]
- Measurement of NK cell-induced epithelial cell activation and viability [Time frame: day 1 to day 2555]
Eligibility criteria
Inclusion criteria
Cases asthma controlled, uncontrolled excluding exacerbation, uncontrolled asthma exacerbation, and healthy volunteers:
- Consent form read, understood, approved and signed before any study procedure
- Membership of a social security scheme or beneficiary of such a scheme
- Patient aged over 18
Cases asthma controlled, uncontrolled excluding exacerbation, uncontrolled exacerbation:
\- Diagnosis of severe asthma confirmed by a respirologist at an expert centre
Case asthma controlled:
\- Asthma control confirmed by a lung specialist from an expert centre
Case uncontrolled asthma excluding exacerbation:
\- Uncontrolled asthma confirmed by a lung specialist from an expert centre
Case uncontrolled asthma with exacerbation:
\- Current exacerbation
Exclusion criteria
Cases asthma controlled, uncontrolled excluding exacerbation, uncontrolled asthma exacerbation, and healthy volunteers:
- Person subject to a legal protection measure
- Vulnerable population: minors, persons under guardianship or trusteeship or persons deprived of their rights to liberty by court order.
- women with a known pregnancy
- Inability or refusal to comply with research requirements
- Active or weaned smoker > 15 PA
- Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or opioids in the 10 days prior to inclusion
Case patient with asthma:
\- Coexistence of a chronic inflammatory disease other than asthma
Case healthy volunteers:
\- Coexistence of an inflammatory pathology
Exclusion criteria
Cases asthma: Pregnancy during follow-up Cases healthy volunteers: Total IgE level greater than 100 kU/L (measured on the study sample)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Hôpital NORD - AP-HM, Clinique des bronches, de l'allergie et du sommeil — Marseille
Identifiers
NCT: NCT06015256 · C21-75 · 2022-A00651- 42