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

NCT ID: NCT04412044

Last Updated: 2020-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2019-03-01

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Mepolizumab Injection [Nucala]

Intervention Type DRUG

Patients receive monthly injection with 100 mg mepolizumab

Interventions

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Mepolizumab Injection [Nucala]

Patients receive monthly injection with 100 mg mepolizumab

Intervention Type DRUG

Other Intervention Names

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Anti-IL5 treatment

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Tatjana Decaesteker

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tatjana Decaesteker

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Other Identifiers

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s58608

Identifier Type: -

Identifier Source: org_study_id

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