A Prospective Study on Optimizing Treatment for ABPA

Shanghai Zhongshan Hospital100 enrolled

Overview

This study is being done to evaluate the efficacy of treatment using oral glucocorticoid, anti-fungal agent, anti-IgE mAb for patient with ABPA.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Allergic Bronchopulmonary Aspergillosis

Interventions

Prednisone tabletDRUG

Basic medication for allergic airway inflammation such as asthma and ABPA, to relieve inflammation. Reduction may failed if disease exacerbate.

itraconazoleDRUG

Anti-fungal medication to reduce fugal load.

OmalizumabBIOLOGICAL

Anti-IgE monoclonal antibody, used for high IgE allergic disease.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 6 months after last treatment dose

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to 6 months after last treatment dose

Central Contacts

Meiling Jin, MD

CONTACT

+86 13701640522 mljin118@163.com

Data from ClinicalTrials.gov

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