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

NCT03453021 | Completed

• 1 other identifier: 38RC16.137
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Eosinophilic

Keywords

asthma; mepolizumab; corticosteroids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Asthma control

  Every month during 13 months

• Improving quality of life

  Every month during 13 months

• Improvement of respiratory functional explorations, Forced Expiratory Volume

  Every month during 13 months

• Decrease in the number of exacerbations

  Assessed every month during 13 months

• Improvement of respiratory functional explorations

  Every month during 13 months

Study Arms (1)

mepolizumab

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

Drug: Mepolizumab

Interventions

Mepolizumab DRUG

mepolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients included are those who have obtained the temporary authorization for nominative use for mepolizumab

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

La Tronche, 38700, France

Location

Related 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.

  PMID: 25199060 BACKGROUND

• 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.

  PMID: 25199059 BACKGROUND

MeSH Terms

Conditions

Pulmonary Eosinophilia; Asthma

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Margaux Isnard, Resident

  University Hospital, Grenoble

  STUDY CHAIR

• Laure Geneletti, Resident

  University Hospital, Grenoble

  STUDY CHAIR

• Audrey Lehmann, Ph

  University Hospital, Grenoble

  STUDY CHAIR

• Pierrick Bedouch, PhD

  University Hospital, Grenoble

  STUDY CHAIR

• Sébastien Chanoine

  University Hospital, Grenoble

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 13 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: January 25, 2016
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

FR (1)