A multi-centre, open label, single arm, 32-week treatment study in subjects with severe eosinophilic asthma not optimally controlled with current omalizumab treatment who are switched from omalizumab to mepolizumab 100mg subcutaneous (study number 204471- the OSMO study)
- Conditions
- asthmabronchial asthma10006436
- Registration Number
- NL-OMON43415
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
* At least 12 years (NL: 18 years) of age.
* Asthma for *2 years that meets the National Heart and Lung Institute or GINA guidelines.
* Persistent airflow obstruction (*18 years: FEV1 <80% predicted, 12-17 years: <90% predicted) or FEV1/FVC ratio <0.8).
* Eosinophilic asthma, see protocol page 25 for details.
* Well-documented requirement for regular treatment with high-dose inhaled corticosteroid in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids, see protocol page 25 for details.
* Additional controller medication, besides ICS: current treatment for at least 3 months or failure in the past 12 months for at least 3 successive months.
* ACQ-5 score *1.5.
* Omalizumab based on weight and IgE levels for at least the 4 months.
* History of two or more exacerbations in the past 12 months. For subjects receiving omalizumab for *8 months: at least one exacerbation must have occurred while on omalizumab treatment, see protocol page 26 for details.
* Adequate contraception for females of childbearing potential.
* Presence of a known pre-existing, clinically important lung condition other than asthma.
* Diagnosis of chronic hepatitis B, as evidenced by positive Hepatitis B surface antigen.
* Clinically significant cardiovascular disease uncontrolled with standard treatment, see protocol page 28 for details.
* Other conditions that could lead to elevated eosinophils, see protocol page 28 for details.
* Known immunodeficiency, other than that explained by the use of corticosteroids for asthma.
* Current smokers or former smokers with a smoking history of *10 pack years see protocol page 29 for details.
* Pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method