NCT06015256Recruiting
Characterization of Natural Killer Cells in Severe Asthma Patients in Comparison With Control Subjects
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 448 (estimated)
- First submitted
- 10 Jul 2023
- Start date
- 7 Sept 2023
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Diseases
- Asthma
- NCT number
- NCT06015256
What you commit to
- Study type: Interventional
- Planned participants: 448
- From 7 Sept 2023 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
- Cases asthma: Pregnancy during follow-up Cases healthy volunteers: Total IgE level greater than 100 kU/L (measured on the study sample)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital NORD - AP-HM, Clinique des bronches, de l'allergie et du sommeil Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.