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Completed

NCT Number: NCT03453021

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mepolizumab

Drug

Primary outcomes

  1. Effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma.

    Time frame: 13 months

    Rate of decrease in systemic corticosteroids between the day of the first injection and one month after the last injection.

Secondary outcomes

  1. Asthma control

    Time frame: Every month during 13 months

    Asthma Control Questionnaire (ACT)

  2. Improving quality of life

    Time frame: Every month during 13 months

    Asthma Quality of Life Questionnaire (AQLQ)

  3. Improvement of respiratory functional explorations, Forced Expiratory Volume

    Time frame: Every month during 13 months

    Forced Expiratory Volume

  4. Decrease in the number of exacerbations

    Time frame: Assessed every month during 13 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.

  5. Improvement of respiratory functional explorations

    Time frame: Every month during 13 months

    Vital Capacity

  6. Improvement of respiratory functional explorations

    Time frame: Every month during 13 months

    Forced Vital Capacity

  7. Improvement of respiratory functional explorations

    Time frame: Every month during 13 months

    FEV/FVC

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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

Acronym: Mepolizumab

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 2, 2018
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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