Examining Natural Killer Cells in Severe Asthma Patients
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
This study is testing how natural killer cells in the immune system affect people with severe asthma, especially during asthma attacks caused by viruses, by comparing them to healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 448 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06015256 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of natural killer (NK) cells in patients with severe asthma compared to healthy control subjects. It aims to understand how these immune cells contribute to asthma exacerbations, particularly those triggered by viral infections. Participants will provide blood samples for analysis, allowing researchers to characterize NK cell activity and function in the context of severe asthma. The study focuses on patients diagnosed with severe asthma, both controlled and uncontrolled, as well as healthy volunteers.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a confirmed diagnosis of severe asthma, either controlled or uncontrolled.
Not a fit: Patients with mild asthma or those not meeting the inclusion criteria, such as minors or individuals under legal protection, may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to new insights into asthma management and potential therapeutic targets for patients with severe asthma.
How similar studies have performed: While the role of NK cells in asthma is not well-established, similar studies investigating immune responses in asthma have shown promising results, suggesting potential for novel insights.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Marseille
- Hôpital NORD - AP-HM, Clinique des bronches, de l'allergie et du sommeil — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Pascal Chanez, PU-PH
- Email: pascal.chanez@univ-amu.fr
- Phone: +334.91.96.58.64
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.