IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency (IVIG)

April 28, 2016 updated by: Hae-Sim Park, Ajou University School of Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immune Globulin
Immunoglobulin G Deficiency Associated with persistent asthma subtypes
Drug: Immune Globulin
6 months once a month intravenous immunoglobulin (400mg/kg/4weeks)
Other Names:
  • Immunoglobulin G Deficiency

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: hae-sim park, Department of medicine, Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-CT4-12-405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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