A Prospective Study on Optimizing Treatment for ABPA

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Two-center, Clinical Study to Optimize the Treatment for Allergic Bronchopulmonary Aspergillosis (ABPA)

Conditions
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Allergic Bronchopulmonary Aspergillosis

Intervention / Treatment
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* Drug: Prednisone tablet
* Drug: itraconazole
* Biological: Omalizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anti-fungal agent plus OCS<br>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 | Drug: Prednisone tablet<br>* Basic medication for allergic airway inflammation such as asthma and ABPA, to relieve inflammation. Reduction may failed if disease exacerbate.<br>Drug: itraconazole<br>* Anti-fungal medication to reduce fugal load.<br>|
| Active Comparator: anti-IgE mAb plus OCS<br>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 | Drug: Prednisone tablet<br>* Basic medication for allergic airway inflammation such as asthma and ABPA, to relieve inflammation. Reduction may failed if disease exacerbate.<br>Biological: Omalizumab<br>* Anti-IgE monoclonal antibody, used for high IgE allergic disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of exacerbation: the exacerbation times indicated by symptoms and clinical index | 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. | Up to 6 months after last treatment dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ST.George's respiratory questionnaire | The SGRQ is a classic respiratory questionnaire including the symptoms, activity, and impact to life. The higher score means better disease control. | Up to 6 months after last treatment dose | 
| asthma control test questionnaire | 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. | Up to 6 months after last treatment dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omalizumab, Allergic Bronchopulmonary Aspergillosis, anti-fungal agent, oral corticosteroids