Phenotypic and Functional Characterization of Neutrophils and Eosinophils in Severe Asthma Treated With Biotherapy

NCT05972213 | Unknown

• 1 other identifier: APHP230345
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Neutrophils and eosinophils can have different functions. Depending on their environment, they can be more or less active, with more or less inflammatory activity. Biotherapies can reduce the number of inflammatory cells in the blood and bronchi. However, it is not known whether they have the ability to modify the functions of the remaining cells. The aim of this study is to better understand the functioning of eosinophilic and neutrophil polynuclear drugs involved in the response to biotherapies in severe asthma. The hypothesis is that biotherapies modify the inflammatory functions of polynuclear cells, which would contribute to the effect of the drug on asthma.

Conditions

Asthma

Keywords

severe asthma; biotherapies

Outcome Measures

Primary Outcomes (1)

• Measurement of the difference between the studied parameters of polynuclear cells measured at 6 months compared to those measured at the start of biotherapy.

  The main objective will be to characterize the longitudinal evolution of markers measured at 6 months after initiation of biotherapy. These parameters will be studied on a fresh blood sample collected peripherally on a 7 mL EDTA (Ethylenediaminetetraacetic acid) tube and 5 mL dry tube on the day of inclusion at the time of day hospital or pulmonology consultation, before initiation and during a follow-up pneumology consultation/day hospital at 6 months post-initiation.

  3 months for the longitudinal group and 9 months for the cross-sectional group

Secondary Outcomes (3)

• Measure the level of asthma control 6 months after the start of treatment, defined by the ACT score

  3 months for the longitudinal group and 9 months for the cross-sectional group

• Measure the number of exacerbations in the previous 6 months

  3 months for the longitudinal group and 9 months for the cross-sectional group

• Measure the type of biotherapy used

  3 months for the longitudinal group and 9 months for the cross-sectional group

Study Arms (2)

Longitudinal group

25 patients anticipated. Patients with : * Uncontrolled asthma: ACT score \< 20 and/or at least one exacerbation in the last 6 months * Naïve biotherapy * Indication for initiation of biotherapy according to the referring pulmonologist (omalizumab, mepolizumab, benralizumab, dupilumab)

Cross-sectional group

80 patients anticipated. * Patient on biotherapy (omalizumab, mepolizumab, benralizumab, dupilumab) for at least 6 months. * Controlled asthma (ACT \> 20 and no exacerbation for 6 months) or uncontrolled asthma (ACT \< 20 and/or at least 1 exacerbation for 6 months).

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe asthmatic patients followed in the Pneumology A department at Bichat Hospital.

You may qualify if:

• years ≤ Age \< 85 years
• Severe asthma as defined by ERS/ATS (European Respiratory Society/American Thoracic Society) 2014: asthma requiring high doses of ICS (inhaled corticosteroid) combined with another control therapy (such as long-acting bronchodilators), whether or not patients are controlled
• Longitudinal group:
• Uncontrolled asthma: ACT score \< 20 and/or at least one exacerbation in the last 6 months
• Naïve about biotherapy
• Indication for the initiation of biotherapy according to the referring pulmonologist (omalizumab, mepolizumab, benralizumab, dupilumab)
• Cross-sectional group:
• Patient on biotherapy (omalizumab, mepolizumab, benralizumab, dupilumab) for at least 6 months.
• Controlled asthma (ACT \> 20 and no exacerbation for 6 months) or uncontrolled asthma (ACT \< 20 and/or at least 1 exacerbation for 6 months).

You may not qualify if:

• Refusal to participate or opposition to data processing
• Patient under guardianship or with curators
• Patient on immunosuppressant (other than corticosteroids)
• Treatment with biotherapy for another indication
• Patient not affiliated to a social security scheme or state medical aid

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

1 ml of serum 1ml of plasma

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Camille Taillé, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camille Taillé, MD, PhD

CONTACT

01 40 25 68 63; camille.taille@aphp.fr

Luc De Chaisemartin, MD

CONTACT

01 40 25 85 21; luc.de-chaisemartin@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: August 2, 2023
• Study Start: July 21, 2023
• Primary Completion: April 21, 2024
• Study Completion: May 21, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)