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IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency (IVIG)

Primary Purpose

Asthma

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Immune Globulin
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Immunoglobulin G Deficiency

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient from over 16 years to under 75 years
  • Patients diagnosed with asthma over six months ago
  • immunoglobulin G subtypes who were diagnosed with immune deficiency

  • more than 2 years Upper and lower respiratory tract infections

    , and asthma exacerbations in this regard.

  • ① calculated creatinine clearance ≧ 50ml/min

    • ALT and AST <x 3 times the upper limit of normal

      • ALP <x 3 times the upper limit of normal

        • total bilirubin <x 1.5 times the upper limit of normal

Exclusion Criteria:

  • within six months of the onset of the experiment who received immunoglobulin therapy
  • immune globulin for those with a history of hypersensitivity reactions
  • six months ago, another clinical trial participants.
  • Systemic steroids and immunomodulators, such as asthma control that may affect the resources required drug administration.
  • pregnant or lactating women.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Immune Globulin

    Arm Description

    Immunoglobulin G Deficiency Associated with persistent asthma subtypes

    Outcomes

    Primary Outcome Measures

    Infection rate
    6 months after treatment compared to before treatment 6 months

    Secondary Outcome Measures

    lung funtion
    - Lung function (FEV1) compared
    steroid
    - Systemic steroid dose and the number of uses
    antibiotic
    - The frequency and duration of antibiotic
    asthma syptoms
    - The frequency of asthma exacerbations
    Questionnaire
    - Asthma Quality of Life (AQOL)
    Questionnair
    - Asthma control score (K-ACT)
    IgG subclass
    - Before and after treatment serum IgG subclass
    Cytokines
    - Cytokines serum levels before and after treatment
    adverse events
    - The frequency of adverse events

    Full Information

    First Posted
    November 11, 2013
    Last Updated
    April 28, 2016
    Sponsor
    Ajou University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01992328
    Brief Title
    IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency
    Acronym
    IVIG
    Official Title
    IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    January 2017 (Anticipated)
    Study Completion Date
    January 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ajou University School of Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Immunoglobulin G deficiency subtypes in patients with asthma six months once a month intravenous immunoglobulin (400mg/kg/4weeks) infection in treatment-related effect on reducing the frequency of asthma exacerbations appreciate.
    Detailed Description
    Patients Registration •It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms. Procedure •six months once a month intravenous immunoglobulin (400mg/kg/4weeks)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Immunoglobulin G Deficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Immune Globulin
    Arm Type
    Experimental
    Arm Description
    Immunoglobulin G Deficiency Associated with persistent asthma subtypes
    Intervention Type
    Drug
    Intervention Name(s)
    Immune Globulin
    Other Intervention Name(s)
    Immunoglobulin G Deficiency
    Intervention Description
    6 months once a month intravenous immunoglobulin (400mg/kg/4weeks)
    Primary Outcome Measure Information:
    Title
    Infection rate
    Description
    6 months after treatment compared to before treatment 6 months
    Time Frame
    6months
    Secondary Outcome Measure Information:
    Title
    lung funtion
    Description
    - Lung function (FEV1) compared
    Time Frame
    6 months
    Title
    steroid
    Description
    - Systemic steroid dose and the number of uses
    Time Frame
    6 months af
    Title
    antibiotic
    Description
    - The frequency and duration of antibiotic
    Time Frame
    6months
    Title
    asthma syptoms
    Description
    - The frequency of asthma exacerbations
    Time Frame
    6months
    Title
    Questionnaire
    Description
    - Asthma Quality of Life (AQOL)
    Time Frame
    6months
    Title
    Questionnair
    Description
    - Asthma control score (K-ACT)
    Time Frame
    6months
    Title
    IgG subclass
    Description
    - Before and after treatment serum IgG subclass
    Time Frame
    6months
    Title
    Cytokines
    Description
    - Cytokines serum levels before and after treatment
    Time Frame
    6months
    Title
    adverse events
    Description
    - The frequency of adverse events
    Time Frame
    6months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient from over 16 years to under 75 years Patients diagnosed with asthma over six months ago immunoglobulin G subtypes who were diagnosed with immune deficiency more than 2 years Upper and lower respiratory tract infections , and asthma exacerbations in this regard. ① calculated creatinine clearance ≧ 50ml/min ALT and AST <x 3 times the upper limit of normal ALP <x 3 times the upper limit of normal total bilirubin <x 1.5 times the upper limit of normal Exclusion Criteria: within six months of the onset of the experiment who received immunoglobulin therapy immune globulin for those with a history of hypersensitivity reactions six months ago, another clinical trial participants. Systemic steroids and immunomodulators, such as asthma control that may affect the resources required drug administration. pregnant or lactating women.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    hae-sim park
    Organizational Affiliation
    Department of medicine, Ajou University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency

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