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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Mepolizumab Injection [Nucala]

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asthmatics; 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	Drug: Mepolizumab Injection [Nucala]; Patients receive monthly injection with 100 mg mepolizumab; Other Names: Anti-IL5 treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway inflammation	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).	Day 1 and after 6 months
Change in Forced Expiratory Volume in 1 seconds (FEV1)	The forced expiratory Volume in 1 second will be measured using spirometry	Day 1 and after 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokine pattern in the airways	Cytokines concentrations (pg/ml) will also be determined in sputum supernatant using a U-plex assay.	Day 1 and after 6 months
Cytokine pattern in the bloodstream	Cytokines concentrations (pg/ml) will also be determined in serum using a U-plex assay.	Day 1 and after 6 months
Change in asthma control	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.	Day 1 and after 6 months
Biomarkers for airway inflammation	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)	Day 1 and after 6 months

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Tatjana Decaesteker, KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: s58608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No