Clinical Trials Logo
  1. Home
  2. Asthma; Eosinophilic
  3. NCT03453021

Effect of Mepolizumab on Decrease of Systemic Corticosteroids in Patients With Severe Eosinophilic Asthma — Mepolizumab  

Asthma; Eosinophilic Clinical Trial

Official title:
Effet du Mepolizumab Sur la décroissance de la corticothérapie systémique Chez Des Patients Avec un Asthme éosinophilique sévère Etude Observationnelle, Suivi de Cohorte Via Une ATU Nominative

Clinical Trial Summary

The primary objective of the study is to measure the effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma.

Asthma is a chronic inflammatory disease of the airways that affects 5 to 10% of adults and children. Despite current treatments that are often effective, 10% of patients are not controlled by inhaled therapies. These severe asthma require regular use of systemic corticosteroids in 30 to 40% of cases. In this context, the use of glucocorticoids is associated with many more or less serious adverse effects, but still affecting the patient's quality of life. Several treatments have already been proven to save systemic steroids (theophylline, anti-leukotrienes, golimumab ...). On the other hand, none is currently recommended because of a risk / benefit ratio that is too high.

Mepolizumab is a human monoclonal antibody that binds to and inactivates interleukin 5. It has recently been shown to be effective in reducing the daily dose of oral corticosteroids and in reducing exacerbations in these patients with severe eosinophilic asthma. It also reduces the number of eosinophils in the blood and sputum and improves the quality of life.

Patients will receive a subcutaneous injection of 100mg mepolizumab every 4 weeks for one year, for a total of 12 injections.

In France, this treatment was subject to a Temporary Authorization for Nominative Use in severe eosinophilic asthma and is reserved for hospital use.

The injections will be done in HDJ Pneumology CHU Grenoble Alpes and patients will be followed monthly during injections and one month after the end of injections.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03453021
Study type Observational [Patient Registry]
Source University Hospital, Grenoble
Contact
Status Completed
Phase
Start date January 25, 2016
Completion date October 31, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT04742504 - Interaction Between Benralizumab and Basophils in Eosinophilic Asthma
Recruiting NCT04565483 - Predictive Signature of Benralizumab Response Phase 4
Completed NCT04181190 - Effects of Anti-IL5 Biological Treatments on Blood IgE Levels in Severe Asthmatic Patients
Recruiting NCT05787678 - Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion
Completed NCT04456270 - Asthma Control in a Dutch Primary Care Population
Not yet recruiting NCT05091385 - Efficacy of Mepolizumab in Polish Patients With Severe Eosinophilic Asthma
Recruiting NCT05078281 - Patients With Severe Eosinophilic Asthma Treated With Benralizumab
Recruiting NCT04512521 - Functional Lung MRI for Early Treatment Response Assessment for Patients With Eosinophilic Asthma
Recruiting NCT05813288 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma (EXHALE-3) Phase 3
Recruiting NCT04319705 - Anti-viral Effects of Azithromycin in Patients With Asthma and COPD Phase 4
Recruiting NCT06288516 - BenRalizumab Effect on Airway Remodeling in Severe asTHma Phase 4
Active, not recruiting NCT03733535 - Evaluating the Effect of Benralizumab in Severe, Poorly-controlled Eosinophilic Asthma Using Inhaled Hyperpolarized 129-Xenon MRI N/A
Not yet recruiting NCT05241769 - The Influence of Inhaled CorticoSteroids Adherence on Treatment Response to Mepolizumab in Severe Eosinophilic Asthma
Not yet recruiting NCT05404763 - Mepolizumab and Physical Activity in Severe Asthma
Not yet recruiting NCT04924478 - Evaluation of Volatile Organic Compounds in Mepolizumab Therapy
Recruiting NCT05748600 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma Phase 3
Recruiting NCT05763121 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma. Phase 3
Active, not recruiting NCT04612556 - Efficacy of Mepolizumab in Severe Asthmatics on a Long Term (MESILICO)
Completed NCT04710134 - Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma Phase 4
Not yet recruiting NCT05144087 - The Influence of Mepolizumab on Structural and Inflammatory Cells in Severe Eosinophilic Asthma