Effect of Biologicals on Alternative Functions of Eosinophils in Severe Asthma

NCT04520165 | Active Not Recruiting Results

• 1 other identifier: 214077
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will measure different cytokines in the sputum (interleukin ((IL))-3, granulocyte-macrophage colony-stimulating factor ((GM-CSF)), IL5, IL-13, IL-33, IL-4, IL-25 thymic stromal lymphopoietin ((TSLP)) and eotaxin-1 ) and in the blood to evaluate their ability to predict the response after 6 months and 1 year of treatment with a biologic treatment (anti-IgE, anti-IL5, anti-IL5R) in terms of reduction in exacerbations and corticosteroid use, improvement in Forced expiratory volume in the first second (FEV1) (+200ml), in asthma control (ACQ decrease \>0.5, ACT increase \>3), in asthma quality of life (increase in AQLQ score \> 0.5) and the effect on sputum and blood inflammation.

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (2)

• Presence of Prognostic Markers of Remission in the Sputum Cell Compartment or Not

  Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater or equal to 80% predicted and/or an improvement of FEV1 greater or equal to 10% and a blood eosinophil count lower than 300 cells/microliter. Markers of remission in the sputum cell profile were investigated.

  1 year follow-up

• Presence of Prognostic Markers (Mediators) of Remission in the Sputum or Not

  Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater or equal to 80% predicted and/or an improvement of FEV1 greater or equal to 10% and a blood eosinophil count lower than 300 cells/microliter. Markers ( inflammatory mediators) of remission in the sputum were investigated.

  1 year follow-up

Secondary Outcomes (2)

• is EPX in the Sputum of Prognostic Marker of ACT Improvement in the Sputum or Not ?

  1 year follow-up

• Is IL-5 in the Sputum a Prognosis Marker for Improvement of FEV1 Post-treatment or Not ?

  1 year follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Severe asthmatic patients recruited through the outpatient clinic and pulmonary rehabilitation centre (CHU, Sart-Tilman, Liege). Asthma and severe asthma is diagnosed as described in the GINA guidelines (http://ginasthma.org/).

You may qualify if:

• Severe asthmatics seen in the Asthma Clinic of CHU of Liege who agree to undergo complete visit at baseline and after 6 months and 1 year of treatment with a biologic and sign informed consent.

You may not qualify if:

• none

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU Liege

Liège, Liege, 4000, Belgium

Location

Related Publications (4)

• Moermans C, Deliege E, Pirottin D, Poulet C, Guiot J, Henket M, da Silva J, Louis R. Suitable reference genes determination for real-time PCR using induced sputum samples. Eur Respir J. 2019 Dec 4;54(6):1800644. doi: 10.1183/13993003.00644-2018. Print 2019 Dec.

  PMID: 31601710 BACKGROUND

• Delvaux M, Henket M, Lau L, Kange P, Bartsch P, Djukanovic R, Louis R. Nebulised salbutamol administered during sputum induction improves bronchoprotection in patients with asthma. Thorax. 2004 Feb;59(2):111-5. doi: 10.1136/thorax.2003.011130.

  PMID: 14760148 BACKGROUND

• Schleich F, Graff S, Nekoee H, Moermans C, Henket M, Sanchez C, Paulus V, Guissard F, Donneau AF, Louis R. Real-word experience with mepolizumab: Does it deliver what it has promised? Clin Exp Allergy. 2020 Jun;50(6):687-695. doi: 10.1111/cea.13601. Epub 2020 Apr 14.

  PMID: 32198794 BACKGROUND

• Moermans C, Brion C, Bock G, Graff S, Gerday S, Nekoee H, Poulet C, Bricmont N, Henket M, Paulus V, Guissard F, Louis R, Schleich F. Sputum Type 2 Markers Could Predict Remission in Severe Asthma Treated With Anti-IL-5. Chest. 2023 Jun;163(6):1368-1379. doi: 10.1016/j.chest.2023.01.037. Epub 2023 Feb 3.

  PMID: 36740095 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole induced sputum Serum

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

Results Point of Contact

• Title: Dr Florence Schleich
• Organization: CHU-Uliege

fschleich@chuliege.be

003243667881

Study Officials

• Florence Schleich

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: January 1, 2014
• Primary Completion: January 26, 2023
• Study Completion: August 31, 2025
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-07

Locations

BE (1)