Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06015256

Characterization of Natural Killer Cells in Severe Asthma Patients in Comparison With Control Subjects

Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2025-04-25

448

Participants Needed

1

Research Sites

364 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Characterization of Natural Killer Cells in Severe Asthma Patients in Comparison With Control Subjects

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed consent form before any study procedure
  • Member or beneficiary of a social security scheme
  • Aged over 18 years
  • Diagnosis of severe asthma confirmed by a lung specialist at an expert center (for asthma cases)
  • Asthma control status confirmed by a lung specialist at an expert center (for controlled asthma cases)
  • Uncontrolled asthma confirmed by a lung specialist at an expert center (for uncontrolled asthma excluding exacerbation cases)
  • Current asthma exacerbation (for uncontrolled asthma with exacerbation cases)
Not Eligible

You will not qualify if you...

  • Subject to legal protection measures
  • Minor, under guardianship or trusteeship, or deprived of liberty by court order
  • Known pregnancy
  • Unable or unwilling to comply with study requirements
  • Active or former smoker with more than 15 pack-years
  • Treatment with NSAIDs or opioids within 10 days prior to inclusion
  • Coexisting chronic inflammatory disease other than asthma (for asthma cases)
  • Coexisting inflammatory disease (for healthy volunteers)
  • Pregnancy during study follow-up (for asthma cases)
  • Total IgE level greater than 100 kU/L measured on study sample (for healthy volunteers)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital NORD - AP-HM, Clinique des bronches, de l'allergie et du sommeil

Marseille, France, 13915

Actively Recruiting

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Research Team

P

Pascal Chanez, PU-PH

CONTACT

C

Catherine Duez, CRCN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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