A Prospective Study on Optimizing Treatment for ABPA

NCT05129033 | Unknown

• 1 other identifier: 2020ZSLC26
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Allergic Bronchopulmonary Aspergillosis

Keywords

Allergic Bronchopulmonary Aspergillosis; anti-fungal agent; Omalizumab; oral corticosteroids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• ST.George's respiratory questionnaire

  Up to 6 months after last treatment dose

• asthma control test questionnaire

  Up to 6 months after last treatment dose

Study Arms (2)

anti-fungal agent plus OCS

ACTIVE COMPARATOR

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; Drug: itraconazole

anti-IgE mAb plus OCS

ACTIVE COMPARATOR

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; Biological: Omalizumab

Interventions

Prednisone tablet DRUG

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

anti-IgE mAb plus OCS; anti-fungal agent plus OCS

itraconazole DRUG

Anti-fungal medication to reduce fugal load.

anti-fungal agent plus OCS

Omalizumab BIOLOGICAL

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

anti-IgE mAb plus OCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Related Publications (6)

• Agarwal R. Allergic bronchopulmonary aspergillosis. Chest. 2009 Mar;135(3):805-826. doi: 10.1378/chest.08-2586.

  PMID: 19265090 BACKGROUND

• Agarwal R, Aggarwal AN, Gupta D, Jindal SK. Aspergillus hypersensitivity and allergic bronchopulmonary aspergillosis in patients with bronchial asthma: systematic review and meta-analysis. Int J Tuberc Lung Dis. 2009 Aug;13(8):936-44.

  PMID: 19723372 BACKGROUND

• Agarwal R, Nath A, Aggarwal AN, Gupta D, Chakrabarti A. Aspergillus hypersensitivity and allergic bronchopulmonary aspergillosis in patients with acute severe asthma in a respiratory intensive care unit in North India. Mycoses. 2010 Mar 1;53(2):138-43. doi: 10.1111/j.1439-0507.2008.01680.x. Epub 2009 Jan 24.

  PMID: 19207831 BACKGROUND

• Agarwal R, Chakrabarti A, Shah A, Gupta D, Meis JF, Guleria R, Moss R, Denning DW; ABPA complicating asthma ISHAM working group. Allergic bronchopulmonary aspergillosis: review of literature and proposal of new diagnostic and classification criteria. Clin Exp Allergy. 2013 Aug;43(8):850-73. doi: 10.1111/cea.12141.

  PMID: 23889240 BACKGROUND

• Mou Y, Ye L, Ye M, Yang D, Jin M. A retrospective study of patients with a delayed diagnosis of allergic bronchopulmonary aspergillosis/allergic bronchopulmonary mycosis. Allergy Asthma Proc. 2014 Mar-Apr;35(2):e21-6. doi: 10.2500/aap.2014.35.3731.

  PMID: 24717781 BACKGROUND

• Agarwal R, Gupta D, Aggarwal AN, Saxena AK, Chakrabarti A, Jindal SK. Clinical significance of hyperattenuating mucoid impaction in allergic bronchopulmonary aspergillosis: an analysis of 155 patients. Chest. 2007 Oct;132(4):1183-90. doi: 10.1378/chest.07-0808. Epub 2007 Jul 23.

  PMID: 17646221 BACKGROUND

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary

Interventions

Prednisone; Itraconazole; Omalizumab

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Meiling Jin, MD

  Department of Respiratory, Zhongshan Hospital, Fudan University Shanghai, China

  STUDY CHAIR

Central Study Contacts

Meiling Jin, MD

CONTACT

+86 13701640522; mljin118@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2021
• First Posted: November 22, 2021
• Study Start: November 15, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share