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

This study is currently recruiting participants.
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01164241
First received: July 15, 2010
Last updated: March 14, 2014
Last verified: November 2013

July 15, 2010
March 14, 2014
June 2010
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Complete list of historical versions of study NCT01164241 on ClinicalTrials.gov Archive Site
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Natural History of Diseases Associated With Allergic Inflammation: Atopic Dermatitis and Genetic and Congenital Diseases Associated With Atopic Pathways
Natural History of Atopic Dermatitis and Other Genetic/Congenital Diseases Associated With Allergic Inflammation

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).

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 600 primary subjects over 5 years. In addition, approximately 300 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.

Observational
Time Perspective: Prospective
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  • Atopic Dermatitis
  • Netheron's Syndrome
  • Piebaldism
  • Hyper IgE Syndrome
  • Ichthyosis
  • Anaphylaxis
  • Severe Allergy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
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  • INCLUSION CRITERIA:

    1. Subject or unaffected relatives must:

      1. 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

      2. 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

      3. Be an unaffected relative of a patient enrolled in the protocol.
    2. Have a private physician to provide local continuity of care.
    3. 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.
    4. 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.

Healthy Volunteer must:

  1. Be at least 18 years old and no greater than 80 years old.
  2. Have no history of recent, active, moderate to severe atopic dermatitis.
  3. Be willing to have samples stored for research and genetic testing.
  4. 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:

  1. 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.
  2. Inability or refusal to undergo study procedures.
  3. Inability to participate for the duration of the study.

Any unaffected relative or healthy volunteer with any of the following criteria will be excluded:

  1. 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.
  2. Inability or refusal to undergo study procedures.
Both
2 Years to 80 Years
Yes
Contact: Michelle R O'Brien, R.N. (301) 443-8341 obrienm@mail.nih.gov
Contact: Kelly D Stone, M.D. (301) 435-0993 stonek@niaid.nih.gov
United States
 
NCT01164241
100148, 10-I-0148
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Kelly D Stone, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP