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

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ClinicalTrials.gov Identifier: NCT03453021
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.


Condition or disease Intervention/treatment
Asthma; Eosinophilic Drug: Mepolizumab

Study Type : Observational [Patient Registry]
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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
Actual Study Start Date : January 25, 2016
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids
Drug Information available for: Mepolizumab

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma. [ Time Frame: 12 months ]
    Rate of decrease in systemic corticosteroids between the day of the first injection and one month after the last injection.


Secondary Outcome Measures :
  1. Asthma control [ Time Frame: Every month during 12 months ]
    Asthma Control Questionnaire (ACT)

  2. Improving quality of life [ Time Frame: Every month during 12 months ]
    Asthma Quality of Life Questionnaire (AQLQ)

  3. Improvement of respiratory functional explorations [ Time Frame: Every month during 12 months ]
    Forced Expiratory Volume, Vital Capacity, Forced Vital Capacity, FEV/FVC

  4. Decrease in the number of exacerbations [ Time Frame: Assessed every month during 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients included are those who have obtained the temporary authorization for nominative use for mepolizumab
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453021


Locations
France
University Hospital Grenoble
La Tronche, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Study Chair: 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

Publications:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03453021     History of Changes
Other Study ID Numbers: 38RC16.137
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University Hospital, Grenoble:
asthma
mepolizumab
corticosteroids

Additional relevant MeSH terms:
Asthma
Pulmonary Eosinophilia
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases