Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992328
Recruitment Status : Unknown
Verified April 2016 by Hae-Sim Park, Ajou University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hae-Sim Park, 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Immune Globulin Phase 3

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)


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency
Study Start Date : December 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: Immunoglobulin G Deficiency




Primary Outcome Measures :
  1. Infection rate [ Time Frame: 6months ]
    6 months after treatment compared to before treatment 6 months


Secondary Outcome Measures :
  1. lung funtion [ Time Frame: 6 months ]
    - Lung function (FEV1) compared

  2. steroid [ Time Frame: 6 months af ]
    - Systemic steroid dose and the number of uses

  3. antibiotic [ Time Frame: 6months ]
    - The frequency and duration of antibiotic

  4. asthma syptoms [ Time Frame: 6months ]
    - The frequency of asthma exacerbations

  5. Questionnaire [ Time Frame: 6months ]
    - Asthma Quality of Life (AQOL)

  6. Questionnair [ Time Frame: 6months ]
    - Asthma control score (K-ACT)

  7. IgG subclass [ Time Frame: 6months ]
    - Before and after treatment serum IgG subclass

  8. Cytokines [ Time Frame: 6months ]
    - Cytokines serum levels before and after treatment

  9. adverse events [ Time Frame: 6months ]
    - The frequency of adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992328


Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: hae-sim park Department of medicine, Ajou University School of Medicine

Layout table for additonal information
Responsible Party: Hae-Sim Park, Professor, Department of medicine, Ajou University School of Medicine, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01992328     History of Changes
Other Study ID Numbers: MED-CT4-12-405
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Keywords provided by Hae-Sim Park, Ajou University School of Medicine:
Immunoglobulin G Deficiency
Additional relevant MeSH terms:
Layout table for MeSH terms
IgG Deficiency
Immune System Diseases
Dysgammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs