Clinical trial NCT05129033: A Prospective Study on Optimizing Treatment for ABPA
Official title: A Prospective, Two-center, Clinical Study to Optimize the Treatment for Allergic Bronchopulmonary Aspergillosis (ABPA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergic Bronchopulmonary Aspergillosis
Keywords: Allergic Bronchopulmonary Aspergillosis
anti-fungal agent
Omalizumab
oral corticosteroids
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of exacerbation: the exacerbation times indicated by symptoms and clinical index
timeFrame: Up to 6 months after last treatment dose
Secondary outcomes:
measure: ST.George's respiratory questionnaire
timeFrame: Up to 6 months after last treatment dose
measure: asthma control test questionnaire
timeFrame: Up to 6 months after last treatment dose
Other outcomes:
Locations:
Study officials:
affiliation: Department of Respiratory, Zhongshan Hospital, Fudan University Shanghai, China
name: Meiling Jin, MD
role: STUDY_CHAIR
References:
citation: Agarwal R. Allergic bronchopulmonary aspergillosis. Chest. 2009 Mar;135(3):805-826. doi: 10.1378/chest.08-2586.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.