drugset / Trial / NCT04159519
A Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicentre, randomised, open-label, parallel-group, active-controlled, phase IV study to assess the reduction of daily Symbicort® maintenance to anti-inflammatory reliever treatment only in participants with severe eosinophilic asthma on Fasenra® treatment, while maintaining asthma control.
Timeline
- Start
- 2020-07-27
- Primary completion
- 2023-01-31
- Completion
- 2023-01-31
Publications
- Jackson DJ, Heaney LG, Humbert M, Kent BD, Shavit A, Hiljemark L, Olinger L, Cohen D, Menzies-Gow A, Korn S; SHAMAL Investigators. Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): a randomised, multicentre, open-label, phase 4 study. Lancet. 2024 Jan 20;403(10423):271-281. doi: 10.1016/S0140-6736(23)02284-5. Epub 2023 Dec 7.
- Butler CA, Heaney LG. Fractional exhaled nitric oxide and asthma treatment adherence. Curr Opin Allergy Clin Immunol. 2021 Feb 1;21(1):59-64. doi: 10.1097/ACI.0000000000000704.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 200 ug | Inhaled |
| Subject | Budesonide | Small molecule | 400 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 6 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 12 ug | Inhaled |
| Background | Benralizumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Background | Salbutamol | Unknown | 100 ug | Inhaled |