Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06015256

Characterization of Natural Killer Cells in Severe Asthma Patients Compared With Controls Identifying Biomarkers and Response During Virus-Induced Exacerbations

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

448

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Asthma is a widespread chronic lung condition affecting around 300 million people globally. It involves bronchial inflammation, hyperreactivity, and tissue changes, causing symptoms like coughing, difficulty breathing, and wheezing due to airway obstruction. The disease can worsen with flare-ups often triggered by viral infections, especially rhinoviruses. This research aims to study natural killer (NK) cells in severe asthma, focusing on molecules they express differently compared to healthy individuals. The goal is to find biomarkers to help diagnose and monitor severe asthma and its flare-ups, particularly during virus-induced exacerbations. Participants include people with severe asthma in different states—controlled, uncontrolled without exacerbation, and uncontrolled with exacerbation—as well as healthy volunteers as controls. The study involves collecting blood samples to analyze NK cells and their interaction with bronchial epithelial cells. Researchers will examine how NK cells respond to rhinovirus infections in laboratory settings, both alone and with lung cells, to identify molecules involved in these interactions. During the study, participants will provide blood samples and undergo assessments over a period that can last up to about seven years. Researchers will track changes in molecules on NK cells, measure NK cell activation, and evaluate how NK cells affect lung cell activation and viability. This long-term follow-up aims to improve understanding of severe asthma mechanisms, potentially leading to better disease monitoring and treatment strategies.

CONDITIONS

Brief 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...

  • 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
  • Diagnosis of severe asthma confirmed by a respirologist at an expert centre for asthma cases
  • Asthma control status confirmed by a lung specialist for controlled, uncontrolled excluding exacerbation, or exacerbation cases
Not Eligible

You will not qualify if you...

  • Person subject to a legal protection measure
  • Vulnerable populations including minors, persons under guardianship or trusteeship, or deprived of liberty by court order
  • Known pregnancy
  • Inability or refusal to comply with research requirements
  • Active or former smokers with more than 15 pack-years
  • Treatment with NSAIDs or opioids within 10 days prior to inclusion
  • Coexistence of a chronic inflammatory disease other than asthma for asthma patients
  • Coexistence of any inflammatory disease for healthy volunteers
  • Pregnancy during follow-up for asthma patients
  • Total IgE level greater than 100 kU/L for healthy volunteers (measured on study sample)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for consent and eligibility assessment

Sample Collection

Duration - Up to approximately 7 years (day 1 to day 2555)

Participants provide blood samples to analyze natural killer cell characteristics and responses.

Periodic blood sample collections over the study duration

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

C

Catherine Duez, CRCN

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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