Asthma bronchial Asthma
Conditions
Interventions
This studyy is an international multi-center and applicable for the Low-Interventional Study based on EU regulation, so the title of the research topic will be described as "intervention research." Ho
Sponsors
Howarth Peter
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or over 2. Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by their physician for the treatment of asthma, as per local label. 3. No NUCALA use in the 6 months prior to enrollment (unless as stated in inclusion criteria 2) 4. Participants with >=60% predicted FEV1 and =<4 exacerbations per year, as confirmed by the physician 5. Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria) 6. Written informed consent 5. Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria) 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Investigator concerns about participant willingness to adhere to biologic treatment for any reason 2. Participants currently on mOCS or intramuscular corticosteroids 3. Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment 4. Participating in an interventional study with a treatment intervention 5. Other clinically significant respiratory conditions (e.g., bronchiectasis, pulmonary fibrosis) 6. Current smokers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Describe the proportion of patients that achieved clinical remission at 12 months, in the principal stratum of patients adherent to NUCALA | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Summarize the rate of clinically significant asthma exacerbations in patients over the follow-up period, in the principal stratum of patient adherent to NUCALA 2. Describe the proportion of patients that achieved OCS sparing and 3 component clinical remission at 12 months, in the principal stratum of patient adherent to NUCALA 3. Evaluate the change from baseline in HRQoL, in the principal stratum of patient adherent to NUCALA | — |
Countries
Belgium, Canada, Germany, Italy, Japan, Poland, Spain, USA
Contacts
Public ContactTakashi Sato
Syneos Health Clinical Japan K.K.
Outcome results
None listed