Effect of Anti-interleukin 5 (IL5) Therapy on Sputum Cells and Cytokines
1 other identifier
interventional
22
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
Started Sep 2016
Typical duration for phase_4 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedJune 2, 2020
May 1, 2020
1.7 years
May 28, 2020
May 28, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Cytokine pattern in the airways
Day 1 and after 6 months
Cytokine pattern in the bloodstream
Day 1 and after 6 months
Change in asthma control
Day 1 and after 6 months
Biomarkers for airway inflammation
Day 1 and after 6 months
Study Arms (1)
Asthmatics
EXPERIMENTALPatients 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
Interventions
Patients receive monthly injection with 100 mg mepolizumab
Eligibility Criteria
You may qualify if:
- 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
- Anti-IL5 treatment prescribed by the physician
You may not qualify if:
- Not completing all visits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tatjana Decaesteker
KU Leuven
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 28, 2020
First Posted
June 2, 2020
Study Start
September 1, 2016
Primary Completion
May 1, 2018
Study Completion
March 1, 2019
Last Updated
June 2, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share