Ignite Creation Date:
2024-05-05 @ 10:40 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01164241
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2010-07-15
Brief Title:
Natural History of Severe Allergic Inflammation and Reactions
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History of Severe Allergic Inflammation and Reactions
Status:
COMPLETED
Status Verified Date:
2024-07-18
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:
None
Brief Summary:
Background
- Allergic inflammation is central to allergy-related diseases and disorders such as asthma food allergies and atopic dermatitis Atopic dermatitis commonly called eczema is a chronic noncontagious skin condition usually starting in the first years of life which causes itching and scaling of an individual s skin Because atopic dermatitis is a common condition in children who have allergy-related diseases including asthma researchers are interested in studying both individuals with atopic dermatitis and their close relatives parents and children to better understand how allergy-related diseases develop and progress In addition some patients with inherited disorders with features including atopic dermatitis or other aspects of allergy such as food allergy asthma hay fever hives and others will also be seen
Objectives
- To study the natural history of diseases of allergic inflammation such as atopic dermatitis or genetic disorders associated with allergic inflammation
Eligibility
Children and adolescents between 1 month and 21 years of age who have a documented history of moderate to severe atopic dermatitis
Individuals between 1 month and 80 years of age who have a suspected genetic or inherited allergy disorder related to atopic dermatitis or allergic pathways
Child and adult relatives of eligible participants will also be studied on this protocol
Design
The study will require one initial visit to the National Institutes of Health Clinical Center lasting 1-5 days as well as any required follow-up visits for treatment and research studies Participants will receive treatment for atopic dermatitis and other allergic diseases as part of the study for up to 1 year
Participants will have some or all of the following tests as part of this study
A detailed physical examination and medical history
Allergy skin prick testing to examine participants responses to different allergens
Blood samples for additional allergen testing testing the immune system and other research purposes
Skin punch biopsy to take a skin sample
Lung function tests to measure airflow from the lungs and inflammation
Food-related tests to diagnose potential food allergies
Leukapheresis to collect white blood cells only
Research samples including stool specimens saliva samples buccal swabs to collect cells from the inside of the cheek and skin cell samples
Clinical digital photography to provide images of affected and healthy skin
Participants will be asked to return for follow-up visits and tests for up to 1 year after the initial visits
- Allergic inflammation is central to allergy-related diseases and disorders such as asthma food allergies and atopic dermatitis Atopic dermatitis commonly called eczema is a chronic noncontagious skin condition usually starting in the first years of life which causes itching and scaling of an individual s skin Because atopic dermatitis is a common condition in children who have allergy-related diseases including asthma researchers are interested in studying both individuals with atopic dermatitis and their close relatives parents and children to better understand how allergy-related diseases develop and progress In addition some patients with inherited disorders with features including atopic dermatitis or other aspects of allergy such as food allergy asthma hay fever hives and others will also be seen
Objectives
- To study the natural history of diseases of allergic inflammation such as atopic dermatitis or genetic disorders associated with allergic inflammation
Eligibility
Children and adolescents between 1 month and 21 years of age who have a documented history of moderate to severe atopic dermatitis
Individuals between 1 month and 80 years of age who have a suspected genetic or inherited allergy disorder related to atopic dermatitis or allergic pathways
Child and adult relatives of eligible participants will also be studied on this protocol
Design
The study will require one initial visit to the National Institutes of Health Clinical Center lasting 1-5 days as well as any required follow-up visits for treatment and research studies Participants will receive treatment for atopic dermatitis and other allergic diseases as part of the study for up to 1 year
Participants will have some or all of the following tests as part of this study
A detailed physical examination and medical history
Allergy skin prick testing to examine participants responses to different allergens
Blood samples for additional allergen testing testing the immune system and other research purposes
Skin punch biopsy to take a skin sample
Lung function tests to measure airflow from the lungs and inflammation
Food-related tests to diagnose potential food allergies
Leukapheresis to collect white blood cells only
Research samples including stool specimens saliva samples buccal swabs to collect cells from the inside of the cheek and skin cell samples
Clinical digital photography to provide images of affected and healthy skin
Participants will be asked to return for follow-up visits and tests for up to 1 year after the initial visits
Detailed Description:
Background
Allergic inflammation is central to the pathogenesis of allergic diseases including atopic dermatitis asthma allergic rhinitis and food allergy These disorders are common affecting up to 50 million Americans and their pathophysiology remains poorly understood Among allergic diseases atopic dermatitis is common with a prevalence of up to 20 in children It is associated with the most dramatic elevations of IgE levels and most prominent T-helper type 2 cell Th2 inflammation and treatment remains challenging Atopic dermatitis eosinophilic inflammation and systemic immediate hypersensitivity reactions are heralding manifestation of allergic disease in many children making these ideal disorders for studying the effector mechanisms promoting the development and progression of allergic diseases In addition to these manifestations there are also a number of characterized genetic and congenital diseases most presenting in childhood that have prominent allergic manifestations including dermatitis or affect atopic pathways These disorders provide further opportunity for advancing our understanding of the genetics and pathophysiology of diseases of allergic inflammation The NIAID Laboratory of Allergic Diseases LAD has a long interest in exploring the mechanisms of allergic inflammation Utilizing the resources of the LAD and the NIH Clinical Center we will advance our understanding of allergic inflammation and the genetics and pathogenesis of allergic diseases through the study of these patients The findings of this protocol will have implications for improved diagnosis treatment and prevention of allergic diseases including atopic asthma
Objectives
The overall goal of this exploratory protocol is to study the natural history of individuals with severe allergic inflammation and hypersensitivity reactions focusing on individuals and families with known or suspected inherited or acquired genetic causes for these clinical manifestations Research studies obtained from blood skin saliva bone marrow and other tests obtained from participants will be used to explore the genetic immunologic structural and microbiologic abnormalities of these diseases Research studies obtained from blood samples allergy skin testing and skin biopsies of unaffected relatives and healthy volunteers will be used as controls for assays and genetic tests Results of research studies will be correlated with clinical features of allergic manifestations of disease and response to therapy
Eligibility
Subjects eligible for enrollment in this study include children and a subset of adults with a known or suspected inherited or acquired genetic allergic disorder leading to severe allergic inflammation or reactions Unaffected relatives of an enrolled subject both children and adults and healthy adult volunteers will also be eligible for separate enrollment
Design
The initial enrollment for this protocol will be 1500 primary subjects In addition approximately 500 healthy or affected parents siblings or other relatives may be enrolled for initial history and clinical and research laboratory evaluation only Approximately 150 unrelated healthy adult volunteers will also be enrolled Affected subjects in this study will receive standard care for allergic diseases both outpatient and inpatient during the period of enrollment and will receive extensive evaluation as clinically indicated in addition to research studies
Allergic inflammation is central to the pathogenesis of allergic diseases including atopic dermatitis asthma allergic rhinitis and food allergy These disorders are common affecting up to 50 million Americans and their pathophysiology remains poorly understood Among allergic diseases atopic dermatitis is common with a prevalence of up to 20 in children It is associated with the most dramatic elevations of IgE levels and most prominent T-helper type 2 cell Th2 inflammation and treatment remains challenging Atopic dermatitis eosinophilic inflammation and systemic immediate hypersensitivity reactions are heralding manifestation of allergic disease in many children making these ideal disorders for studying the effector mechanisms promoting the development and progression of allergic diseases In addition to these manifestations there are also a number of characterized genetic and congenital diseases most presenting in childhood that have prominent allergic manifestations including dermatitis or affect atopic pathways These disorders provide further opportunity for advancing our understanding of the genetics and pathophysiology of diseases of allergic inflammation The NIAID Laboratory of Allergic Diseases LAD has a long interest in exploring the mechanisms of allergic inflammation Utilizing the resources of the LAD and the NIH Clinical Center we will advance our understanding of allergic inflammation and the genetics and pathogenesis of allergic diseases through the study of these patients The findings of this protocol will have implications for improved diagnosis treatment and prevention of allergic diseases including atopic asthma
Objectives
The overall goal of this exploratory protocol is to study the natural history of individuals with severe allergic inflammation and hypersensitivity reactions focusing on individuals and families with known or suspected inherited or acquired genetic causes for these clinical manifestations Research studies obtained from blood skin saliva bone marrow and other tests obtained from participants will be used to explore the genetic immunologic structural and microbiologic abnormalities of these diseases Research studies obtained from blood samples allergy skin testing and skin biopsies of unaffected relatives and healthy volunteers will be used as controls for assays and genetic tests Results of research studies will be correlated with clinical features of allergic manifestations of disease and response to therapy
Eligibility
Subjects eligible for enrollment in this study include children and a subset of adults with a known or suspected inherited or acquired genetic allergic disorder leading to severe allergic inflammation or reactions Unaffected relatives of an enrolled subject both children and adults and healthy adult volunteers will also be eligible for separate enrollment
Design
The initial enrollment for this protocol will be 1500 primary subjects In addition approximately 500 healthy or affected parents siblings or other relatives may be enrolled for initial history and clinical and research laboratory evaluation only Approximately 150 unrelated healthy adult volunteers will also be enrolled Affected subjects in this study will receive standard care for allergic diseases both outpatient and inpatient during the period of enrollment and will receive extensive evaluation as clinically indicated in addition to research studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10-I-0148 | None | None | None |