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Natural History of Severe Allergic Inflammation and Reactions

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ClinicalTrials.gov Identifier: NCT01164241
Recruitment Status : Recruiting
First Posted : July 16, 2010
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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 visit(s).

Condition or disease
PGM3 Deficiency Eosinophilic and/or Atopic Dermatitis OSMR Deficiency Primary Localized Cutaneous Amyloidosis Hereditary Alpha-tryptasemia

Detailed Description:
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

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Study Type : Observational
Estimated Enrollment : 2150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History of Severe Allergic Inflammation and Reactions
Actual Study Start Date : July 12, 2010


Group/Cohort
1
Eczema
2
unaffected relatives
3
healthy volunteers
4
other allergic phenotypes



Primary Outcome Measures :
  1. SCORAD [ Time Frame: At initial and single follow up visit 1-2 months after. ]
    Severity of atopic dermatitis, only taken when present.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Referrals for severe, familial or atypical allergic disease from throughout the country and world-- either physician or self referrals.
Criteria
  • INCLUSION CRITERIA:
  • 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 severe allergic inflammation or hypersensitivity, that began in the first 5 years of life, that is moderate to severe, and with continued inflammation or

      recurrent flares in the preceding 3 months. Patients greater than 21 years of age with a history of disease 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 known or suspected genetic or congenital disorder associated with severe allergic inflammation or

      hypersensitivity, as determined by the PI or AIs.

      OR

    3. Be an a 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 the 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 and genetic testing; for unaffected relatives, be willing to donate blood and/or undergo allergy skin testing, in addition to having blood samples stored for future research and genetic testing.
  • 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, and able to provide informed consent.

    2. Have no history of severe or recurrent allergic diseases or reactions.

  • Be willing to have samples stored for research and genetic testing.

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.
  • Inability to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164241


Contacts
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Contact: Judith Bandoh (301) 259-7230 judy.bandoh@nih.gov
Contact: Jonathan J Lyons, M.D. (301) 443-5250 lyonsjj@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Jonathan J Lyons, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01164241    
Other Study ID Numbers: 100148
10-I-0148
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: July 23, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Tryptase
Dermatitis
Eosinophilia
Anaphylaxis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Amyloidosis
Inflammation
Pathologic Processes
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Proteostasis Deficiencies
Metabolic Diseases