Asthma Asthma
Conditions
Interventions
All patients will be treated with tezepelumab.
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients will be aged 18 - 80 years and have a confirmed diagnosis of asthma according to the European Respiratory Society (ERS) clinical guidelines (2022). history of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250µg fluticasone propionate dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.Pre-bronchodilator FEV1 of =80% predicted within 12 months prior to visit 1 (or at screening)History of =1 exacerbation in the previous year ACQ =1.5 at screening Severe allergic eosinophilic asthma must be diagnosed (in medical record) by the treating physician Blood eosinophil count =150 cells per microliter (this inclusion criteria is only for the patients who are biologic-naïve) at screening or documented in the previous 30 days. Patients have to be capable to understand the informed consent form and sign the written informed consent formFor patients switching from omalizumab: being actively treated with omalizumab for a minimum of 16 weeks is required before entering the study (start of run in period) and to have at least a washout period of 28 days.
Exclusion criteria
Exclusion criteria: Current smokers or former smokers with a smoking history of =15 pack years. Chronic pulmonary disorders other than asthma Current malignancy or previous malignancy in remission <12 months Inability or absence of willingness to withhold morning dose of bronchodilator(s) on visit days. An exacerbation requiring OCS in the run-in phase. Any other condition that, according to the investigator, may affect the outcome of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter is change in specific image based airway volumes and resistance after 12 weeks of treatment with tezepelumab. The entire study period is scheduled to take approximately 16 weeks for each individual subject. Each patient will be treated with Tezepelumab 210 mg once every 4 weeks subcutaneous injected (in total 3 injections per patient). This treatment is provided according to standard of care. During this period we will observe clinical parameters, lung function parameters, eosinophil counts and HRCT changes. | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine the change in SiVaw and other FRI parameters at 4 and 12 weeks, for example: Specific image based resistance (SiRaw) at FRC and TLC Image based lobe volumes Internal lobar airflow distribution (defined as the percentage of air going to every lobe when inhaling from FRC to TLC and is calculated for every lobe) Mucus plugs (score and volume) Airtrapping Aerosol deposition | — |
Countries
Netherlands
Contacts
Public ContactL Conemans
Maastricht Universitair Medisch Centrum +
Outcome results
None listed