Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346398
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2006-06-27
Brief Title:
Promoting Tolerance to Common Allergens in High-Risk Children Global Prevention of Asthma in Children GPAC Study
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Multicenter Controlled Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease ITN025AD
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GPAC
Brief Summary:
The purpose of this study is to determine whether early childhood exposure to common allergens substances that can trigger allergies and asthma can prevent the development of asthma in children at high risk for developing the disease
Detailed Description:
Researchers suspect that allergies to common inhaled allergens such as house dust mite cat dander and grass pollens are a major cause of childhood asthma Recent evidence suggests that if allergies to inhaled allergens are prevented this can cause changes in the immune system that may inhibit the development of asthma Although strategies to prevent allergies generally focus on avoiding the allergen complete avoidance of the common allergens linked to asthma would require extreme measures and is impractical
Oral mucosal immunoprophylaxis OMIP therapy is an allergy treatment that can induce long-lasting immune tolerance in people already suffering from allergies By exposing the patient to small repeated but increasing doses of the problem allergen over a long period of time the patients immune system is eventually desensitized to that particular allergen OMIP therapy has been shown to be safe in children as young as 2 years old This study will evaluate if OMIP therapy against common inhaled allergens is safe and effective in preventing the development of asthma in children at high risk for developing the disease Children enrolled in this study have been diagnosed with eczema or food allergies and have a family history of eczema allergic rhinitis or asthma
There are two groups in this study The experimental arm participants will receive OMIP therapy a mixture of house dust mite cat and timothy grass allergens as daily oral drops under the tongue for 1 year Placebo arm participants will receive an allergen free placebo solution Participants will be followed for an additional 3 years to see whether they develop allergies or asthma and to determine how OMIP affects their immune systems response to allergens There will be 5 study visits in the first year and 6 visits over the next 3 years At all visits participants will be assessed for allergyasthma symptoms will be asked to complete questionnaires and may be asked to provide blood or saliva samples
Oral mucosal immunoprophylaxis OMIP therapy is an allergy treatment that can induce long-lasting immune tolerance in people already suffering from allergies By exposing the patient to small repeated but increasing doses of the problem allergen over a long period of time the patients immune system is eventually desensitized to that particular allergen OMIP therapy has been shown to be safe in children as young as 2 years old This study will evaluate if OMIP therapy against common inhaled allergens is safe and effective in preventing the development of asthma in children at high risk for developing the disease Children enrolled in this study have been diagnosed with eczema or food allergies and have a family history of eczema allergic rhinitis or asthma
There are two groups in this study The experimental arm participants will receive OMIP therapy a mixture of house dust mite cat and timothy grass allergens as daily oral drops under the tongue for 1 year Placebo arm participants will receive an allergen free placebo solution Participants will be followed for an additional 3 years to see whether they develop allergies or asthma and to determine how OMIP affects their immune systems response to allergens There will be 5 study visits in the first year and 6 visits over the next 3 years At all visits participants will be assessed for allergyasthma symptoms will be asked to complete questionnaires and may be asked to provide blood or saliva samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None