Asthma AcuteNKASNCT06015256
Characterization of Natural Killer Cells in Severe Asthma Patients in Comparison With Control Subjects
A study testing blood sample in people with Asthma Acute, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma Acute
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2023to Sep 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Cases asthma: Pregnancy during follow-up Cases healthy volunteers: Total IgE level greater than 100 kU/L (measured on the study sample)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital NORD - AP-HM, Clinique des bronches, de l'allergie et du sommeil
Marseille, 13915
Pascal CHANEZ, PU-PH, +334.91.96.58.64, pascal.chanez@univ-amu.fr
About this study
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
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.
- Conditions
- Asthma Acute
- Being tested
- blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
Blood sample (56mL) taken in a heparin tube
| Study group | Role | What they receive |
|---|---|---|
| Severe uncontrolled asthma in exacerbation | Other | Not described Receives: Biological: blood sample |
| Severe uncontrolled asthma excluding exacerbation | Other | Not described Receives: Biological: blood sample |
| Severe controlled asthma | Other | Not described Receives: Biological: blood sample |
| Healthy volunteers (control group) | Other | Not described Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in expression of one or more molecules on the surface of NK cells
Rationale for choice of primary endpoint: Our aim is to phenotype NK cells in different groups of severe asthma patients compared with control subjects, in order to identify at least one marker of disease discrimination on these cells. We are therefore looking for previously unknown changes in the expression of one or more molecules.
Measured: day 1 to day 2555
Secondary outcomes (2)
Measurement of NK cell activation
Change From Baseline in the expression of CD107, CD69 and interferon-ɣ.
Measured: day 1 to day 2555
Measurement of NK cell-induced epithelial cell activation and viability
Change From Baseline in epithelial cell cohesion, mucin and cytokine (IL-8, type I interferon, IL-33 and TSLP) production
Measured: day 1 to day 2555
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start7 Sep 2023
- Primary completionSep 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AcuteStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015256
- Sponsor's protocol ID
- C21-75
- Other IDs
- 2022-A00651- 42
- Acronym
- NKAS
- Status last verified
- Apr 2025
- First submitted
- 10 Jul 2023
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No