NCT05129033

A Prospective Study on Optimizing Treatment for ABPA

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Allergic Bronchopulmonary Aspergillosis

Interventions

Type	Name	Description
DRUG	Prednisone tablet	Basic medication for allergic airway inflammation such as asthma and ABPA, to relieve inflammation. Reduction may failed if disease exacerbate.
DRUG	itraconazole	Anti-fungal medication to reduce fugal load.
BIOLOGICAL	Omalizumab	Anti-IgE monoclonal antibody, used for high IgE allergic disease.

Timeline

• Start date: 2021-11-15
• Primary completion: 2023-06-30
• Completion: 2023-12-30
• First posted: 2021-11-22
• Last updated: 2021-11-22