A Prospective Study on Optimizing Treatment for ABPA
Primary Purpose
Allergic Bronchopulmonary Aspergillosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prednisone tablet
itraconazole
Omalizumab
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Bronchopulmonary Aspergillosis focused on measuring Allergic Bronchopulmonary Aspergillosis, anti-fungal agent, Omalizumab, oral corticosteroids
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
anti-fungal agent plus OCS
anti-IgE mAb plus OCS
Arm 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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
ST.George's respiratory questionnaire
The SGRQ is a classic respiratory questionnaire including the symptoms, activity, and impact to life. The higher score means better disease control.
asthma control test questionnaire
The ACT is a classic asthma questionnaire recommended by GINA (Global Initiative for Asthma). ACT mainly measures the symptoms. The higher score means better disease control.
Full Information
NCT ID
NCT05129033
First Posted
July 3, 2021
Last Updated
November 19, 2021
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05129033
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2021 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Bronchopulmonary Aspergillosis
Keywords
Allergic Bronchopulmonary Aspergillosis, anti-fungal agent, Omalizumab, oral corticosteroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anti-fungal agent plus OCS
Arm Type
Active Comparator
Arm 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
Arm Title
anti-IgE mAb plus OCS
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Prednisone tablet
Intervention Description
Basic medication for allergic airway inflammation such as asthma and ABPA, to relieve inflammation. Reduction may failed if disease exacerbate.
Intervention Type
Drug
Intervention Name(s)
itraconazole
Intervention Description
Anti-fungal medication to reduce fugal load.
Intervention Type
Biological
Intervention Name(s)
Omalizumab
Intervention Description
Anti-IgE monoclonal antibody, used for high IgE allergic disease.
Primary Outcome Measure Information:
Title
incidence of exacerbation: the exacerbation times indicated by symptoms and clinical index
Description
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.
Time Frame
Up to 6 months after last treatment dose
Secondary Outcome Measure Information:
Title
ST.George's respiratory questionnaire
Description
The SGRQ is a classic respiratory questionnaire including the symptoms, activity, and impact to life. The higher score means better disease control.
Time Frame
Up to 6 months after last treatment dose
Title
asthma control test questionnaire
Description
The ACT is a classic asthma questionnaire recommended by GINA (Global Initiative for Asthma). ACT mainly measures the symptoms. The higher score means better disease control.
Time Frame
Up to 6 months after last treatment dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meiling Jin, MD
Phone
+86 13701640522
Email
mljin118@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meiling Jin, MD
Organizational Affiliation
Department of Respiratory, Zhongshan Hospital, Fudan University Shanghai, China
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19265090
Citation
Agarwal R. Allergic bronchopulmonary aspergillosis. Chest. 2009 Mar;135(3):805-826. doi: 10.1378/chest.08-2586.
Results Reference
background
PubMed Identifier
19723372
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.
Results Reference
background
PubMed Identifier
19207831
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.
Results Reference
background
PubMed Identifier
23889240
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.
Results Reference
background
PubMed Identifier
24717781
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.
Results Reference
background
PubMed Identifier
17646221
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.
Results Reference
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A Prospective Study on Optimizing Treatment for ABPA
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