Asthma
Conditions
Keywords
Immunoglobulin G Deficiency
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)
Interventions
DRUGImmune Globulin
6 months once a month intravenous immunoglobulin (400mg/kg/4weeks)
Sponsors
Ajou University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection rate | 6months | 6 months after treatment compared to before treatment 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| steroid | 6 months af | \- Systemic steroid dose and the number of uses |
| antibiotic | 6months | \- The frequency and duration of antibiotic |
| asthma syptoms | 6months | \- The frequency of asthma exacerbations |
| Questionnaire | 6months | \- Asthma Quality of Life (AQOL) |
| lung funtion | 6 months | \- Lung function (FEV1) compared |
| IgG subclass | 6months | \- Before and after treatment serum IgG subclass |
| Cytokines | 6months | \- Cytokines serum levels before and after treatment |
| adverse events | 6months | \- The frequency of adverse events |
| Questionnair | 6months | \- Asthma control score (K-ACT) |
Outcome results
None listed