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
About this trial
This is an interventional treatment trial for Asthma focused on measuring Immunoglobulin G Deficiency
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.
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
NCT ID
NCT01992328
First Posted
November 11, 2013
Last Updated
April 28, 2016
Sponsor
Ajou University School of Medicine
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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