A Prospective Study on Optimizing Treatment for ABPA

Fudan University

Status: Unknown

Conditions: Allergic Bronchopulmonary Aspergillosis

Treatments: Drug: itraconazole; Drug: Prednisone tablet; Biological: Omalizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05129033

2020ZSLC26

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

anti-fungal agent plus OCS

Active Comparator group

Description:

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

Treatment:

Drug: itraconazole

Drug: Prednisone tablet

anti-IgE mAb plus OCS

Active Comparator group

Description:

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

Treatment:

Biological: Omalizumab

Drug: Prednisone tablet