IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency

NCT ID: NCT01992328

Last Updated: 2016-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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)

Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immune Globulin

Immunoglobulin G Deficiency Associated with persistent asthma subtypes

Group Type EXPERIMENTAL

Immune Globulin

Intervention Type DRUG

6 months once a month intravenous immunoglobulin (400mg/kg/4weeks)

Interventions

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Immune Globulin

6 months once a month intravenous immunoglobulin (400mg/kg/4weeks)

Intervention Type DRUG

Other Intervention Names

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Immunoglobulin G Deficiency

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hae-Sim Park

Professor, Department of medicine, Ajou University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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hae-sim park

Role: PRINCIPAL_INVESTIGATOR

Department of medicine, Ajou University School of Medicine

Other Identifiers

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MED-CT4-12-405

Identifier Type: -

Identifier Source: org_study_id

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