Allergic Bronchopulmonary Aspergillosis
Conditions
Keywords
Allergic Bronchopulmonary Aspergillosis, anti-fungal agent, Omalizumab, oral corticosteroids
Brief summary
This study is being done to evaluate the efficacy of treatment using oral glucocorticoid, anti-fungal agent, anti-IgE mAb for patient with ABPA.
Detailed description
This is a study randomly treating ABPA patients with either anti-fungal agent plus OCS or anti-IgE mAb (omalizumab) plus OCS. OCS is the basic treatment for ABPA by suppressing allergy and inflammation. Prednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to for a total usage of 6 months. Reduction may failed if disease exacerbate. Anti-fungal agent (mainly itraconazole) could reduce the load of fungus but its application is still controversial. The investigators use itraconazole 200mg bid for 8 months and 100mg bid for another 8 months. Omalizumab was given 600mg q4w for at least 6 months. The investigators use Anti-fungal agent and Omalizumab as a supplement to OCS to evaluate the better treatment plan for ABPA patients.
Interventions
Basic medication for allergic airway inflammation such as asthma and ABPA, to relieve inflammation. Reduction may failed if disease exacerbate.
DRUGitraconazole
Anti-fungal medication to reduce fugal load.
BIOLOGICALOmalizumab
Anti-IgE monoclonal antibody, used for high IgE allergic disease.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 18\ 75 years old, male or female * associated past medical history, including asthma, bronchiectasis, COPD ect. * elevated serum total IgE (\>100IU/mL) * elevated aspergillus specific IgE
Exclusion criteria
* According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness). * Pregnancy or breastfeeding * Abnormality of liver or kidney function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of exacerbation: the exacerbation times indicated by symptoms and clinical index | Up to 6 months after last treatment dose | the exacerbation times indicated by symptoms and clinical index, including commom respiratory symptoms such as wheezing, cough, expectation, dyspnea and so on. As well as new shadows in chest CT. Those situation may cause the extreme clinic visit and hospitalization, which could be measured by times or days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ST.George's respiratory questionnaire | Up to 6 months after last treatment dose | The SGRQ is a classic respiratory questionnaire including the symptoms, activity, and impact to life. The higher score means better disease control. |
| asthma control test questionnaire | Up to 6 months after last treatment dose | The ACT is a classic asthma questionnaire recommended by GINA (Global Initiative for Asthma). ACT mainly measures the symptoms. The higher score means better disease control. |
Contacts
Primary ContactMeiling Jin, MD
Outcome results
None listed