Efficacy of Mepolizumab in Severe Asthmatics on a Long Term (MESILICO)

Summary

Interleukin (IL)-5 is the main cytokine responsible for the activation of eosinophils, hence therapeutic strategies have been investigated and developed for clinical use. Biologics targeting IL-5 and its receptor (first mepolizumab and subsequently, reslizumab and benralizumab), have been recently approved and used as add-on therapy for severe eosinophilic asthma resulting in a reduction in the circulating eosinophil count, improvement in lung function and exacerbation reduction in patients with severe asthma.

Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice.

Aim of this clinical study is to evaluate the efficacy of mepolizumab, a humanized IL-5 antagonist monoclonal antibody in patients with late-onset severe eosinophilic asthma with fixed obstruction and to identify the characteristics of non-responders and super-responders under mepolizumab treatment. This study is considered as non-interventional and every procedure included is happening in a clinical routine for the diagnosis and phenotyping of the asthmatic patients.

Hypothesis includes the efficacy of mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction and relation to clinical and inflammatory biomarkers.

Patients will be collected from the outpatient clinics of bronchial asthma from each site included (8 in number) which cover the whole population of Greece.

Overall, this is a prospective multicenter study including eight Pulmonary Clinics. Five Pulmonary University Clinics, two of National Health System and one Army General Hospital in Thessaloniki. The study will include a screening period of up to 2 weeks to assess eligibility and obtain written informed consent, a mepolizumab treatment period of 52 weeks, once every 4 weeks, including follow up visits every 3 months during treatment. The study population will consist of 45 patients with late-onset severe eosinophilic asthma and fixed obstruction receiving mepolizumab, aged 20 and above.

Conditions

• Asthma; Eosinophilic
• Severe Asthma
• Late-Onset Asthma

Interventions

DRUG

Mepolizumab 100 MG [Nucala]

subcutaneous injection once a month

Sponsors & Collaborators

• NHS Pulmonary Clinic G. Papanikolaou Hospital, Thessaloniki, Greece

  collaborator UNKNOWN

• Pulmonary Clinic of Army Hospital Thessaloniki Greece

  collaborator UNKNOWN

• Pulmonary Clinic, Democritus University of Thrace

  collaborator UNKNOWN

• Pulmonary Clinic, University of Ioannina

  collaborator UNKNOWN

• 1st Pulmonary Clinic, Kapodistrian University of Athens

  collaborator UNKNOWN

• 2nd Pulmonary Clinic, Kapodistrian University of Athens

  collaborator UNKNOWN

• NHS 7th Pulmonary Clinic, Sotiria Hospital, Athens

  collaborator UNKNOWN

• Aristotle University Of Thessaloniki

  lead OTHER

Principal Investigators

• Konstantinos Porpodis, Assist Prof · Aristotle University Of Thessaloniki

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-22

Primary Completion

2023-03-15

Completion

2025-03-15

FDA Drug

Yes

Countries

• Greece

Study Locations