IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency

Phase 3

• Conditions: Asthma
• Interventions: Drug: Immune Globulin

• Registration Number: NCT01992328
• Lead Sponsor: Ajou University School of Medicine

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)

Study Timeline

• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Study Start: 2013-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-05-02
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immune Globulin	Immune Globulin	Immunoglobulin G Deficiency Associated with persistent asthma subtypes

Primary Outcome Measures

Name	Time	Method
Infection rate	6months	6 months after treatment compared to before treatment 6 months

Secondary Outcome Measures

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