Asthma
Conditions
Interventions
Every 4 weeks, for 20 weeks, the patient will receive 210 mg of Tezepelumab by
injection under the skin.
Sponsors
Longziekten
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age 18-75 years - Written informed consent - BMI >18 with weight >40kg at inclusion - Documented physician-diagnosed asthma for at least 12 months prior to inclusion (12% reversibility in FEV1 or positive histamine/methacholine provocation test) - Controller regime with medium- or high dosed ICS * Medium: >=250µg and <500µg fluticasone daily * High: >=500µg fluticasone daily * Or bio-equivalent dose of other type of ICS - Stable dose of controller medication other than ICS/LABA (leukotriene receptor inhibitors, theophylline, secondary ICS, LAMA, chromones) - Pre-BD FEV1 value of >= 40% - ACQ >= 1.5 - T2 low profile: * Peripheral blood eosinophils < 150 cells/µL * FeNO < 20 ppb * No clinically proven allergen driven asthma * No need for maintenance OCS - >=2 exacerbation events or >=1 exacerbation with hospitalization in the 12 months prior to inclusion * Exacerbation: burst of OCS for at least 3 days - Reproduction: * Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from screening, and must agree to continue using such precautions for 16 weeks after the final dose of Tezepelumab.
Exclusion criteria
Exclusion criteria: - Current smokers - Stopped smoking <6 months prior to inclusion but >= 10 pack years - Use of immune modulatory drugs, Azithromycin, Montelukast and Theophylline - Concurrent or intercurrent disease that may compromise safety of the patient or may compromise the ability to participate in the trial - Concomitant respiratory disease that will interfere with the evaluation of the product or the interpretation of the results - Evidence of active liver disease - History of cancer - Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 15 days prior to first visit - Pregnant, breastfeeding or lactating females - Unwillingness or inability to follow the procedures outlined in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcomes of single cell sequencing | — |
Countries
Netherlands
Outcome results
None listed