bronchial asthma
Conditions
Interventions
None listed
Sponsors
Juntendo University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects with refractory asthma whose asthma symptoms cannot be controlled by existing treatments and who require tezepelumab treatment under insurance according to the package insert. Subjects receiving treatment with moderate to high doses of inhaled corticosteroids plus at least one controller. Subjects who meet at least one of the following criteria at baseline: (1) At least one exacerbation of asthma has been observed within the past 2 years (2) ACQ-6 score 1.5 or higher or ACT score 20 or lower (3) FEV1 before bronchodilator administration is less than 80% of the predicted value
Exclusion criteria
Exclusion criteria: Subjects with malignancy Current smokers and subjects with a history of smoking within the past 6 months Subjects receiving treatment with other biologics and less than 1 month since last administraion (benralizumab requires 2 months) Subjects who have received bronchial thermoplasty within the past 6 months Subjects with a history of anaphylaxis due to biologics Subjects currently pregnant or breastfeeding Subjects with chronic obstructive pulmonary disease with obvious emphysematous changes Subjects with hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, pulmonary hypertension, sequelae of tuberculosis, diffuse panbronchiolitis, and interstitial pneumonia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in the cell ratio of each peripheral blood immunocompetent cell population (eosinophils, etc.) due to tezepelumab administration up to 24 weeks of tezepelumab treatment for patients with severe asthma that is difficult to control with existing treatments. | — |
Countries
Japan
Contacts
Public ContactNorihiro Harada
Juntendo Hospital, Juntendo University School of Medicine Department of Respiratory Medicine
Outcome results
None listed