Bronchial asthma
Conditions
Interventions
Inject omalizumab 75-375 mg every 2 or 4 weeks subcutaneously
Sponsors
Kyoto University Graduate School of Medicine
Japanese Red Cross Wakayama Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Severe asthma patients who not only meet the Japanese guideline definition of Step4, but are still poorly controlled despite multiple controller medications including high-dose inhaled corticosteroid. 2)Patients whose concentration of serum total IgE is from 30 to 700 IU/ml, and whose body weight is from 30 to 150 kg. 3)Patients who gave consult to the study.
Exclusion criteria
Exclusion criteria: 1)Patients with hypersensitiviry to omalizumab 2)Patients with obstructive lung diseases such as chronic bronchitis or COPD, or bronchiectasis 3)Pregnancy or lactation 4)Patients with non-atopic diseases associated with elevated serum total IgE levels 5)Patients who are considered inappropriate by physicians in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parameters of impulse oscillometry | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Indices of chest computed tomography 2)Indices of airway responsiveness 3)Indices of pulmonary function 4)Eosinophil counts in induced sputum 5)Exhaled nitric oxide concentrations 6)Biamarkers of blood 7)Scores of questionnaires 8)Abnormal lung sounds in auscultation 9)Frequency of execerbations 10)Indices of temporal bone and paranasal sinuses computed tomography 11)Biomarkers of middle-ear effusion and pituita | — |
Countries
Japan
Contacts
Public ContactTomoko Tajiri
Kyoto University Graduate School of Medicine Department of Respiratory Medicine
Outcome results
None listed