Type 2 low asthma in obese and non-obese patients treated with Tezepelumab

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 8

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

- 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