DUAL HOMING MECHANISMS OF EOSINOPHILS TO THE SPUTUM; ONLY ONE OF WHICH IS SENSITIVE FOR MEPOLIZUMAB; The FOOTSTEP study

Phase 1

• Conditions: severe eosinophilic asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-002014-52-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-15
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Age > 18 and younger than 70 years
•Diagnosis of eosinophil asthma despite use of (oral) corticosteroids
•Suitable for sputum induction
•>2.5% sputum eosinophils

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

•Any infection (eg. HIV, Hepatitis, STDs)
•Insulin dependent diabetes
• Smoking at present or in the last 12 months and/or a past history of more than 10 pack years
• Proven allergic bronchopulmonary aspergillosis
•Auto-immune diseases
•Use of medication, excluding:
oAnticonceptives
oPain killers, if used less than once a week
Asthmamedication including steroids

•Exuberant alcohol consumption (for males > 36 glasses per week, for females >24 glasses per week)
•Drug use
•History of cancer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Understanding of the mechanisms underlying eosinophilic inflammation in the lung;Secondary Objective: Better description of the local inflammation in the lung of patients with severe eosinophilic asthma;Primary end point(s): -Lifespans of eosinophils in blood and lungs of eosinophilic asthma (EA) patients in the presence and absence of Mepolizumab;Timepoint(s) of evaluation of this end point: end of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Differences in TH2/TH17 cytokine profile induced by treatment with Mepolizumab.<br>-Difference in eosinophil priming in blood and sputum in eosinophil asthma patients treated with Mepolizumab.<br>-Differences in the presence of eosinophil products in blood and/or sputum in eosinophilic asthma patients treated with Mepolizumab.<br>-Difference in the number of eosinophil progenitors in sputum of eosinophil asthma patients treated with Mepolizumab<br>;Timepoint(s) of evaluation of this end point: end of study