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NCT03453021: Mepolizumab
Effect of Mepolizumab on Decrease of Systemic Corticosteroids in Patients With Severe Eosinophilic Asthma
trial testing Mepolizumab in Asthma; Eosinophilic in 27 participants. Completed in 31 October 2017.
31 October 2017
Quick facts
| Lead sponsor | University Hospital, Grenoble |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 27 |
| Start date | 25 January 2016 |
| Primary completion | 31 October 2017 |
| Estimated completion | 31 October 2017 |
| Sites | 1 location across France |
Drugs / interventions tested
- Mepolizumab (MEPOLIZUMAB) — full drug profile →
Conditions studied
- Asthma; Eosinophilic — all drugs for Asthma; Eosinophilic →
Sponsor
University Hospital, Grenoble
Who can join
18 and older, any sex, with Asthma; Eosinophilic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03453021
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Asthma; Eosinophilic
Currently open trials in the same condition.
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- NCT05144087 — The Influence of Mepolizumab on Structural and Inflammatory Cells in Severe Eosinophilic Asthma · active not recruiting
Other University Hospital, Grenoble trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03453021 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Grenoble
- Last refreshed: 3 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03453021.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing