Last updated on September 2020

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


Brief description of study

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.

Detailed Study Description

This study will be conducted at 25 study sites in 4 countries. The study duration for each participant will be approximately 52-56 weeks. Approximately 240 participants with severe eosinophilic asthma taking high-dose Inhaled corticosteroids/ long-acting 2-agonist (ICS/LABA) who have been treated for severe eosinophilic asthma with at least 3 consecutive doses of Fasenra and have clinically responded since the start of Fasenra treatment (defined for the purpose of this study as an Asthma control questionnaire-5 item (ACQ-5 score) <1.5 at Visit 1 and Visit 2b) will be enrolled into this open-label study. The study consists of a Screening Visit (Visit 1) and 4- to 8-week screening and run-in period (to align the randomisation study visit with the next Fasenra injection), a reduction period of 32 weeks, and a 16-week maintenance period.

Clinical Study Identifier: NCT04159519

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Brest Cedex, France
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Dijon Cedex, France
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Le Kremlin-Bicêtre, France
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Lyon Cedex 4, France
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Cottbus, Germany
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Freiburg, Germany
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Hamburg, Germany
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Hannover, Germany
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Marburg, Germany
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München, Germany
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Belfast, United Kingdom
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Cambridge, United Kingdom
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London, United Kingdom
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Nottingham, United Kingdom
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Recruitment Status: Open


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