IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency

NCT01992328 | Unknown Phase 3 DMC

• 1 other identifier: MED-CT4-12-405
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

Immunoglobulin G Deficiency

Outcome Measures

Primary Outcomes (1)

• Infection rate

  6 months after treatment compared to before treatment 6 months

  6months

Secondary Outcomes (9)

• lung funtion

  6 months

• steroid

  6 months af

• antibiotic

  6months

• asthma syptoms

  6months

• Questionnaire

  6months

Study Arms (1)

Immune Globulin

EXPERIMENTAL

Immunoglobulin G Deficiency Associated with persistent asthma subtypes

Drug: Immune Globulin

Interventions

Immune Globulin DRUG

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

Also known as: Immunoglobulin G Deficiency

Immune Globulin

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ajou University School of Medicine: lead

MeSH Terms

Conditions

Asthma; IgG Deficiency

Interventions

Immunoglobulins

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Dysgammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• hae-sim park

  Department of medicine, Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of medicine, Ajou University School of Medicine

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 2, 2016

Record last verified: 2016-04