A Prospective, Two-center, Clinical Study to Optimize the Treatment for Allergic Bronchopulmonary Aspergillosis (ABPA)
Overview
- Phase
- Not Applicable
- Intervention
- Prednisone tablet
- Conditions
- Allergic Bronchopulmonary Aspergillosis
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 100
- Primary Endpoint
- incidence of exacerbation: the exacerbation times indicated by symptoms and clinical index
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
anti-fungal agent plus OCS
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
Intervention: Prednisone tablet
anti-fungal agent plus OCS
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
Intervention: itraconazole
anti-IgE mAb plus OCS
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
Intervention: Prednisone tablet
anti-IgE mAb plus OCS
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
Intervention: Omalizumab
Outcomes
Primary Outcomes
incidence of exacerbation: the exacerbation times indicated by symptoms and clinical index
Time Frame: 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 Outcomes
- asthma control test questionnaire(Up to 6 months after last treatment dose)
- ST.George's respiratory questionnaire(Up to 6 months after last treatment dose)