Severe asthma
Conditions
Interventions
None listed
Sponsors
Teikyo University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 20 or older 2) Diagnosed as severe asthma at the first dose of mepolizumab 3) Have results of measurement of peripheral blood eosinophil count at the first dose of mepolizumab 4) The number of with asthma exacerbations* from 12 weeks prior to the first mepolizumab dose to the time of the first mepolizumab dose is known 5) Previous mepolizumab treatment for >12 weeks 6) It is possible to obtain written informed consent for participation in this study. *; The definition of asthma exacerbation is as follows. a. Systemic steroids, including oral and IV products, administered for 3 days or more in association with asthma exacerbation (Day of onset; Day of first administration of systemic steroids including oral and IV formulations associated with asthma exacerbation) b. In patients who regularly use oral corticosteroids, at least twice the usual dose for at least 3 days (Day of onset; day when oral steroids at least twice the daily dose were started for at least 3 days with asthma exacerbation) c. Asthma exacerbation requiring visit to the emergency department or hospitalization (Day of onset; date of emergency department visit or hospitalization associated with asthma exacerbation)
Exclusion criteria
Exclusion criteria: 1) There is a significant lack of information recorded in the medical record. 2) Some or all mepolizumab treatments were performed outside the study site 3) Other than the above, the principal investigator subinvestigator judged the participation in the study to be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Frequency of clinically significant asthma exacerbations from the first day of mepolizumab to Week 12-52 2) Changes in the use of systemic steroids from the date of the first dose of mepolizumab to a maximum of 52 weeks later | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Time course of ACQ, ACT, AHQ, FEV1, eosinophil counts, basophil counts, neutrophil counts, lymphocyte counts, FeNO, biomarkers, sinonasal CT/MRI scores, and nasal manifestations from the starting day of mepolizumab treatment to up to 52 weeks. 2) ~ 6) Associations between baseline and clinically significant asthma exacerbations, ACQ, ACT, AHQ, FEV1, and sinonasal CT/MRI scores during mepolizumab treatment: 2) History of smoking >=10 pack-year/< 3) Airway reversible positive/negative 4) Comorbidities 5) Biomarkers 6) Patient background factors (items in Tables 3, 4, and 5) 7) Relationship between change in ACQ, ACT, FEV1, frequency of exacerbations, biomarkers (eosinophil count, ECP), or time points and subsequent improvement in each clinically significant asthma exacerbation, ACQ, ACT, or FEV1 after 4 and 12 weeks of mepolizumab treatment. 8) Post-discontinuation treatment patterns in patients who discontinued mepolizumab. 9) Correlation between sinonasal CT findings and improvement in asthma exacerbations. 10) Effectiveness of mepolizumab on eosinophilic otitis media. | — |
Countries
Japan
Contacts
Public ContactHiroyuki Nagase
Teikyo University School of Medicine Division of Respiratory Medicine and Allergology, Department of Medicine
Outcome results
None listed