Asthma; EosinophilicMepolizumabNCT03453021
Effect of Mepolizumab on Decrease of Systemic Corticosteroids in Patients With Severe Eosinophilic Asthma
An observational study of Asthma; Eosinophilic, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma; Eosinophilic
- What is being tested?
- Mepolizumab
- Type of treatment
- Injection or infusion
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2016to 31 Oct 2017
- How long will I take part?
- 13 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included are those who have obtained the temporary authorization for nominative use for mepolizumab
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Mepolizumab
- Keywords
- asthma, mepolizumab, corticosteroids
- Medical subject headings
- Pulmonary Eosinophilia, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| mepolizumab | Patients will receive a subcutaneous injection of mepolizumab 100 mg every 4 weeks for one year, for a total of 12 injections Receives: Drug: Mepolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 13 months
Secondary outcomes (7)
Asthma control
Asthma Control Questionnaire (ACT)
Measured: Every month during 13 months
Improving quality of life
Asthma Quality of Life Questionnaire (AQLQ)
Measured: Every month during 13 months
Improvement of respiratory functional explorations, Forced Expiratory Volume
Forced Expiratory Volume
Measured: Every month during 13 months
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.
Measured: Assessed every month during 13 months
Improvement of respiratory functional explorations
Vital Capacity
Measured: Every month during 13 months
Improvement of respiratory functional explorations
Forced Vital Capacity
Measured: Every month during 13 months
Improvement of respiratory functional explorations
FEV/FVC
Measured: Every month during 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start25 Jan 2016
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asthma; EosinophilicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
- Target duration
- 13 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaux Isnard, Resident, Study chair, University Hospital, GrenobleLaure Geneletti, Resident, Study chair, University Hospital, GrenobleAudrey Lehmann, Ph, Study chair, University Hospital, GrenoblePierrick Bedouch, PhD, Study chair, University Hospital, GrenobleSébastien Chanoine, Study chair, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453021
- Sponsor's protocol ID
- 38RC16.137
- Acronym
- Mepolizumab
- Status last verified
- Oct 2018
- First submitted
- 26 Feb 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25199060Ortega 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.
PubMed 25199059
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03453021
- Acronym / sponsor ID
- Mepolizumab / 38RC16.137
- Conditions
- Asthma; Eosinophilic
- Keywords
- asthma, mepolizumab, corticosteroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 13 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mepolizumab | – | Drug: MepolizumabPatients will receive a subcutaneous injection of mepolizumab 100 mg every 4 weeks for one year, for a total of 12 injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included are those who have obtained the temporary authorization for nominative use for mepolizumab
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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, ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepolizumab | Drug | mepolizumab |
Primary outcome
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.
7 secondary outcomes
Asthma control
Time frame: Every month during 13 months
Improving quality of life
Time frame: Every month during 13 months
Improvement of respiratory functional explorations, Forced Expiratory Volume
Time frame: Every month during 13 months
Decrease in the number of exacerbations
Time frame: Assessed every month during 13 months
Improvement of respiratory functional explorations
Time frame: Every month during 13 months
Improvement of respiratory functional explorations
Time frame: Every month during 13 months
Improvement of respiratory functional explorations
Time frame: Every month during 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Background: PubMed 25199060Bel 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.
- Background: PubMed 25199059Ortega 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaux Isnard, Resident study chair
University Hospital, Grenoble
Laure Geneletti, Resident study chair
University Hospital, Grenoble
Audrey Lehmann, Ph study chair
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma; Eosinophilic, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma. (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453021, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.