Effect of Anti-interleukin 5 (IL5) Therapy on Sputum Cells and Cytokines

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Mepolizumab Injection [Nucala]

• Registration Number: NCT04412044
• Lead Sponsor: KU Leuven

Brief Summary

22 asthmatics, in which mepolizumab was to be started, gave permission for inclusion and were followed up prospectively. Clinical and lung functional data, sputum analyses and cytokine measurements were analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2018-05-01
• Study Completion: 2019-03-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Last Update Submitted: 2020-05-28
• Study First Posted: 2020-06-02
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• FEV1 < 80% in the last 12 months
• use of high dose inhaled corticosteroids (ICS) in combination with other additional medication or continuous use of oral corticosteroids (OCS)
• at least 2 exacerbations in the last 12 months
• at least 300 blood eosinophils/µl once in the last 12 months and at the time of inclusion
• Anti-IL5 treatment prescribed by the physician

Exclusion Criteria

• Not completing all visits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Asthmatics	Mepolizumab Injection [Nucala]	Patients receive anti-IL5 treatment as part of their prescribed routine. Immunological and clinical parameters will be evaluated at the start of the treatment and after 6 months of treatment

Primary Outcome Measures

Name	Time	Method
Airway inflammation	Day 1 and after 6 months	Bronchial airway inflammation. Differential cell count will be performed on sputum samples, determining eosinophilic (\>3% eosinophils, \<61% neutrophils), neutrophilic (\<3% eosinophils and \>61% neutrophils), pauci-granulocytic (\<3% eosinophils and \<61% neutrophils) and mixed granulocytic airway inflammation (\>3% eosinophils and \>61% neutrophils).
Change in Forced Expiratory Volume in 1 seconds (FEV1)	Day 1 and after 6 months	The forced expiratory Volume in 1 second will be measured using spirometry

Secondary Outcome Measures

Name	Time	Method
Cytokine pattern in the bloodstream	Day 1 and after 6 months	Cytokines concentrations (pg/ml) will also be determined in serum using a U-plex assay.
Change in asthma control	Day 1 and after 6 months	Asthma control will be determined using the Asthma Control Questionnaire (ACQ-6), including 6 questions. Each question will be scored from 0-6 and added together. This final score will be divided by the number of questions. If ACQ-6 \< 0.75 = controlled asthma, ACQ-6 from 0.75-1.5 = partly controlled asthma and ACQ-6 \> 1.5 = uncontrolled asthma.
Cytokine pattern in the airways	Day 1 and after 6 months	Cytokines concentrations (pg/ml) will also be determined in sputum supernatant using a U-plex assay.
Biomarkers for airway inflammation	Day 1 and after 6 months	Fraction exhaled Nitric Oxid (FeNO) will be used as biomarker for eosinophilic airway inflammation. FeNO \< 25 ppb = eosinophilic inflammation less likely, FeNO between 25 and 50 ppm = need further interpretation with additional clinical information, FeNO \> 50 ppm = indication of eosinophilic airway inflammation (according to the American Thoracic Society guidelines)