A Prospective Study on Optimizing Treatment for ABPA
- Conditions
- Allergic Bronchopulmonary Aspergillosis
- Interventions
- Registration Number
- NCT05129033
- Lead Sponsor
- Shanghai Zhongshan Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description anti-IgE mAb plus OCS Prednisone tablet Prednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to stop for a total usage of 6 months Omalizumab is given by subcutaneous injection of 600mg q4w for at least 6 months anti-IgE mAb plus OCS Omalizumab Prednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to stop for a total usage of 6 months Omalizumab is given by subcutaneous injection of 600mg q4w for at least 6 months anti-fungal agent plus OCS Prednisone tablet Prednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to stop for a total usage of 6 months Itraconazole is given orally 200mg bid for 8 months and 100mg bid for another 8 months anti-fungal agent plus OCS itraconazole Prednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to stop for a total usage of 6 months Itraconazole is given orally 200mg bid for 8 months and 100mg bid for another 8 months
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.