A Prospective Study on Optimizing Treatment for ABPA

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT05129033
Status
Unknown

Conditions

  • Allergic Bronchopulmonary Aspergillosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Nov 15, 2021
Status verified
Nov 2021
Primary completion
Jun 30, 2023
Completion
Dec 30, 2023

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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
  • Active Comparator: 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

Primary Outcome Measure

incidence of exacerbation: the exacerbation times indicated by symptoms and clinical index [ Time Frame: Up to 6 months after last treatment dose ]

Central Contacts