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

Asthma; Eosinophilic Clinical Trial

— Mepolizumab  

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 Details — Status: Completed

Administrative data

• NCT number: NCT03453021
• Other study ID #: 38RC16.137
• Status: Completed
• Start date: January 25, 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: October 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Severe eosinophilic asthma

• Patient on inhaled therapy with inhaled corticosteroid and long-acting bronchodilator for at least 6 months

• Patient under oral corticosteroid therapy (prednisolone or prednisone) for at least 6 months and unmodified in the last 4 weeks before the first injection

• Patient able to provide informed and written consent

• Obtaining the temporary authorization for nominative use for mepolizumab

Exclusion Criteria:

• Chronic pulmonary pathology other than asthma

• Active neoplasia

• Active liver disease

• Serious and uncontrolled cardiovascular pathology (LVEF less than 30%, NYHA IV, ...)

• Other eosinophilic pathology (Churg & Strauss syndrome, parasitic infection, ...)

• Hypersensitivity to mepolizumab or excipient

• Immunity disorders

• Patient not affiliated to a social security system

Related Conditions & MeSH terms

• Asthma
• Asthma; Eosinophilic
• Pulmonary Eosinophilia

Intervention

Drug:
• Mepolizumab

Locations

Country	Name	City	State
France	University Hospital Grenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (2)

Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1189-97. doi: 10.1056/NEJMoa1403291. Epub 2014 Sep 8. — View Citation

Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1198-207. doi: 10.1056/NEJMoa1403290. Epub 2014 Sep 8. Erratum in: N Engl J Med. 2015 Apr 30;372(18):1777. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma.	Rate of decrease in systemic corticosteroids between the day of the first injection and one month after the last injection.	13 months
Secondary	Asthma control	Asthma Control Questionnaire (ACT)	Every month during 13 months
Secondary	Improving quality of life	Asthma Quality of Life Questionnaire (AQLQ)	Every month during 13 months
Secondary	Improvement of respiratory functional explorations, Forced Expiratory Volume	Forced Expiratory Volume	Every month during 13 months
Secondary	Decrease in the number of exacerbations	An exacerbation is defined as an episode of progressive degradation, over a few days, of one or more clinical signs, as well as functional parameters of bronchial obstruction.	Assessed every month during 13 months
Secondary	Improvement of respiratory functional explorations	Vital Capacity	Every month during 13 months
Secondary	Improvement of respiratory functional explorations	Forced Vital Capacity	Every month during 13 months
Secondary	Improvement of respiratory functional explorations	FEV/FVC	Every month during 13 months