IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency

Asthma Clinical Trial

— IVIG  

Official title:

IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01992328
• Other study ID #: MED-CT4-12-405
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 11, 2013
• Last updated: April 28, 2016
• Start date: December 2013
• Est. completion date: January 2017

Study information

• Verified date: April 2016
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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.

• ? 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• IgG Deficiency

Intervention

Drug:
• Immune Globulin
6 months once a month intravenous immunoglobulin (400mg/kg/4weeks)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection rate	6 months after treatment compared to before treatment 6 months	6months	No
Secondary	lung funtion	- Lung function (FEV1) compared	6 months	No
Secondary	steroid	- Systemic steroid dose and the number of uses	6 months af	No
Secondary	antibiotic	- The frequency and duration of antibiotic	6months	No
Secondary	asthma syptoms	- The frequency of asthma exacerbations	6months	No
Secondary	Questionnaire	- Asthma Quality of Life (AQOL)	6months	No
Secondary	Questionnair	- Asthma control score (K-ACT)	6months	No
Secondary	IgG subclass	- Before and after treatment serum IgG subclass	6months	No
Secondary	Cytokines	- Cytokines serum levels before and after treatment	6months	No
Secondary	adverse events	- The frequency of adverse events	6months	No