Natural History of Diseases Associated With Allergic Inflammation: Atopic Dermatitis and Genetic and Congenital Diseases Associated With Atopic Pathways

  • STATUS
    Recruiting
  • participants needed
    2150
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 19 March 2021
skin disorder
asthma
allergen
skin prick
hay fever
food allergy
atopy
eczema
urticaria

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 visit(s).

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, 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 is also the first manifestation of allergic disease in many children, making it an ideal disorder for studying the mechanisms of development and progression of allergic diseases. In addition to atopic dermatitis, there are also a number of 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 diseases of allergic inflammation, focusing on subjects with moderate to severe atopic dermatitis or with suspected genetic or congenital disorders associated with allergic inflammation. Research studies 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 unaffective 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 moderate to severe atopic dermatitis or children and adults with a suspected genetic or congenital disorder associated with atopy or affecting an atopic pathway. 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 over 5 years. 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 be also enrolled. Atopic dermatitis 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.

Details
Condition Eczema, ATOPIC DERMATITIS, Dermatitis, Eczema (Atopic Dermatitis), Dermatitis, Atopic, Hand Dermatitis, Eczema (Atopic Dermatitis - Pediatric), Eczéma (Dermatite Atopique), Dermatite Atopique, PLAID, CARD11, CARD14, Hereditary Alpha Trytasemia
Clinical Study IdentifierNCT01164241
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on19 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: Dermatitis or Eczema (Atopic Dermatitis) or CARD11 or CARD14 or Eczema (Atopic Dermatitis - Pediatric) or Eczéma (Dermatite Atopique) or Dermatite Ato...?
Do you have any of these conditions: ATOPIC DERMATITIS or Dermatitis, Atopic or CARD14 or Eczéma (Dermatite Atopique) or Eczema (Atopic Dermatitis) or Eczema or CARD11 or Dermatite Atopiq...?
Do you have any of these conditions: Eczema (Atopic Dermatitis - Pediatric) or Dermatite Atopique or PLAID or Dermatitis or Dermatitis, Atopic or Hereditary Alpha Trytasemia or Hand Derma...?
Do you have any of these conditions: Eczema (Atopic Dermatitis) or CARD11 or Hereditary Alpha Trytasemia or ATOPIC DERMATITIS or Eczema or Dermatite Atopique or PLAID or Hand Dermatitis o...?
Do you have any of these conditions: ATOPIC DERMATITIS or Dermatitis, Atopic or Eczema (Atopic Dermatitis - Pediatric) or PLAID or Hereditary Alpha Trytasemia or Eczema or Dermatitis or E...?
Do you have any of these conditions: Dermatitis, Atopic or CARD11 or CARD14 or Dermatite Atopique or PLAID or Hand Dermatitis or Eczema (Atopic Dermatitis) or Eczema (Atopic Dermatitis - ...?
Do you have any of these conditions: Eczema (Atopic Dermatitis) or Dermatite Atopique or CARD14 or CARD11 or Hand Dermatitis or ATOPIC DERMATITIS or Hereditary Alpha Trytasemia or Dermati...?
Do you have any of these conditions: Eczema (Atopic Dermatitis) or Eczéma (Dermatite Atopique) or PLAID or Dermatite Atopique or CARD11 or Dermatitis or Eczema or ATOPIC DERMATITIS or CAR...?
Do you have any of these conditions: Dermatitis, Atopic or Eczema (Atopic Dermatitis) or Dermatitis or CARD11 or PLAID or Hand Dermatitis or Eczema or ATOPIC DERMATITIS or Eczéma (Dermati...?
Do you have any of these conditions: Dermatitis or Dermatitis, Atopic or PLAID or Eczema (Atopic Dermatitis - Pediatric) or Hereditary Alpha Trytasemia or Dermatite Atopique or Hand Derma...?
Do you have any of these conditions: CARD11 or ATOPIC DERMATITIS or Eczema or Eczema (Atopic Dermatitis - Pediatric) or Dermatite Atopique or PLAID or Dermatitis, Atopic or Hand Dermatiti...?
Do you have any of these conditions: CARD11 or Dermatitis, Atopic or PLAID or CARD14 or Eczema (Atopic Dermatitis - Pediatric) or Eczema or Hand Dermatitis or Hereditary Alpha Trytasemia ...?
Is your age between 2 yrs and 80 yrs?
Do you have any of these conditions: Eczema (Atopic Dermatitis) or ATOPIC DERMATITIS or CARD14 or Eczema (Atopic Dermatitis - Pediatric) or Hand Dermatitis or Eczema or Hereditary Alpha T...?
Do you have any of these conditions: Eczéma (Dermatite Atopique) or Dermatite Atopique or Hand Dermatitis or Dermatitis or Eczema (Atopic Dermatitis - Pediatric) or Dermatitis, Atopic or ...?
Do you have any of these conditions: Eczema (Atopic Dermatitis - Pediatric) or PLAID or Dermatite Atopique or Hereditary Alpha Trytasemia or CARD11 or Dermatitis or Hand Dermatitis or Der...?
Do you have any of these conditions: Dermatitis, Atopic or Eczema or Hereditary Alpha Trytasemia or Dermatitis or Eczéma (Dermatite Atopique) or PLAID or Hand Dermatitis or ATOPIC DERMATI...?
Do you have any of these conditions: Eczema (Atopic Dermatitis - Pediatric) or PLAID or ATOPIC DERMATITIS or Dermatite Atopique or CARD14 or Hereditary Alpha Trytasemia or Dermatitis, Ato...?
Do you have any of these conditions: CARD11 or CARD14 or PLAID or ATOPIC DERMATITIS or Eczema or Hereditary Alpha Trytasemia or Hand Dermatitis or Eczema (Atopic Dermatitis) or Eczéma (De...?
Do you have any of these conditions: Eczema (Atopic Dermatitis) or Eczema (Atopic Dermatitis - Pediatric) or CARD11 or Eczéma (Dermatite Atopique) or CARD14 or ATOPIC DERMATITIS or PLAID ...?
Do you have any of these conditions: Hand Dermatitis or CARD14 or Eczéma (Dermatite Atopique) or Dermatite Atopique or ATOPIC DERMATITIS or Eczema or Dermatitis, Atopic or PLAID or CARD11...?
Do you have any of these conditions: Hereditary Alpha Trytasemia or CARD11 or CARD14 or ATOPIC DERMATITIS or PLAID or Eczema (Atopic Dermatitis) or Dermatitis, Atopic or Dermatitis or Der...?
Gender: Male or Female
Subject or unaffected relatives must
Be at least 2 years of age and less than or equal to 21 years of age at the time of enrollment and have documented history of AD, by modified Hanifin and Rajka criteria, that began in the first 5 years of life, that is moderate to severe, and with continued active flares in the preceding 3 months. Patients greater than 21 years of age with active moderate to severe AD may be enrolled, at the discretion of the PI or AIs, if they have a history of AD in the first 5 years of life and/or, if in the opinion of the PI or AIs, the patient would be of interest to fulfill the objectives of the study
OR
\. Be 2-80 years of age with a suspected genetic or congenital disorder
associated with atopy or affecting an atopic pathway, as determined by the PI
or AIs
OR
\. Be an unaffected relative of a patient enrolled in the protocol
\. Have a private physician to provide local continuity of care
\. Provide a letter of referral, with copies of pertinent medical history and
laboratory studies as indicated, from prospective study participant s
referring physician; this is not a requirement for healthy relatives
\. Be willing to donate blood, buccal swabs, saliva, skin and nasal swabs for
research and clinical studies and for storage to be used for future research
for unaffected relatives, be willing to donate blood and/or undergo allergy
skin testing, in addition to having blood samples stored for future research
\. Pregnant women or women who become pregnant are eligible to participate or
continue participation on the study
Healthy Volunteer must
Be at least 18 years old and no greater than 80 years old
Have no history of recent, active, moderate to severe atopic dermatitis
Be willing to have samples stored for research and genetic testing
For a subset of subjects participating in the cooling cuff procedure, be willing to have research skin biopsies performed

Exclusion Criteria

Any subject with any of the following criteria will be excluded
Presence of conditions that, in the judgment of the investigator or the referring physician, may put the subject at undue risk or make them unsuitable for participation in the study
Inability or refusal to undergo study procedures
Inability to participate for the duration of the study
Any unaffected relative or healthy volunteer with any of the following
criteria will be
excluded
Presence of conditions that, in the judgment of the investigator or the referring physician, may put the subject at undue risk or make them unsuitable for participation in the study
Inability or refusal to undergo study procedures
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