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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
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 3, 2021
    Last Updated
    November 19, 2021
    Sponsor
    Shanghai Zhongshan Hospital
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    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
    background

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    A Prospective Study on Optimizing Treatment for ABPA

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