Type 2 low asthma
Conditions
Interventions
210 mg of Tezepelumab s.c. every 4 weeks for 20 weeks.
Sponsors
Unknown
Eligibility
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 |
|---|---|
| 1) To unravel the mechanisms and downstream effects of Tezepelumab in T2 low asthma, 20 weeks after therapys 2) To identify T2 low biomarkers | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To identify predictive biomarkers for the effect of Tezepelumab in T2 low asthma | — |
Contacts
Public ContactTimothy Chin-See-Chong
Franciscus Gasthuis en Vlietland Ziekenhuis
Outcome results
None listed