Asthma
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 20 years or older at the time of consent Patients who have been receiving the same biologic therapy (omalizumab, mepolizumab, benralizumab, dupilumab, or tezepelumab) for at least 12 months at the time of consent Patients who switch to a long-acting injectable therapy administered every 26 weeks Patients who provide written informed consent after receiving sufficient explanation of the study
Exclusion criteria
Exclusion criteria: Patients who changed biologic therapy within 12 months prior to consent Patients who received unapproved biologic therapies within 12 months prior to consent Patients who received pharmacological treatment for malignancy within 12 months prior to consent Patients deemed inappropriate for participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in treatment satisfaction score from baseline (prior to switching) to 6 months after switching to a long-acting injectable therapy, assessed using a questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in convenience score (baseline, 6 months, and 12 months; questionnaire using a 5-point Likert scale) Change in psychological burden score (baseline, 6 months, and 12 months; questionnaire using a 5-point Likert scale) Change in treatment satisfaction score (baseline, 6 months, and 12 months; questionnaire using a 5-point Likert scale) Change in the proportion of patients achieving clinical remission (baseline and 12 months) Change in the number of asthma exacerbations (comparison between 12 months before and 12 months after switching) Change in Asthma Control Test (ACT) score (baseline, 6 months, and 12 months) Change in lung function (FEV1) (baseline, 6 months, and 12 months) Change in peripheral blood eosinophil count (baseline, 6 months, and 12 months) | — |
Countries
Japan
Contacts
University of Miyazaki Division of Respirology, Rheumatology, Infectious Diseases, and Neurology, Department of Internal Me