IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency

Study Overview
=================
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)

Official Title
-----------------
IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Immune Globulin


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immune Globulin<br>Immunoglobulin G Deficiency Associated with persistent asthma subtypes | Drug: Immune Globulin<br>* 6 months once a month intravenous immunoglobulin (400mg/kg/4weeks)<br>* Other names: Immunoglobulin G Deficiency;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection rate | 6 months after treatment compared to before treatment 6 months | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung funtion | - Lung function (FEV1) compared | 6 months | 
| steroid | - Systemic steroid dose and the number of uses | 6 months af | 
| antibiotic | - The frequency and duration of antibiotic | 6months | 
| asthma syptoms | - The frequency of asthma exacerbations | 6months | 
| Questionnaire | - Asthma Quality of Life (AQOL) | 6months | 
| Questionnair | - Asthma control score (K-ACT) | 6months | 
| IgG subclass | - Before and after treatment serum IgG subclass | 6months | 
| Cytokines | - Cytokines serum levels before and after treatment | 6months | 
| adverse events | - The frequency of adverse events | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunoglobulin G Deficiency