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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00102570 |
This study will evaluate children with allergies and collect medical data and biological specimens from them periodically to learn more about the diseases and gain information that may be useful in developing new treatments.
Patients 6 months to 18 years of age with a possible diagnosis of asthma, rhinitis, anaphylaxis, hives, atopic dermatitis, food allergy, stinging insect allergy, and other allergic and inflammatory diseases may be eligible for this study. Biological parents of patients may also be enrolled to provide a blood sample for genetic studies.
Participants undergo tests appropriate for the diagnosis and management of their allergy. They include the tests outlined below and, when necessary, additional blood tests, tissue biopsies (surgical removal of a small piece of tissue for microscopic examination), computed tomography (CT) or magnetic resonance imaging (MRI).
Condition |
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Hypersensitivity, Immediate |
Study Type: | Observational |
Official Title: | Clinical and Immunological Evaluation of Children With Allergic Disease |
Estimated Enrollment: | 300 |
Study Start Date: | January 2005 |
Atopic disorders, including but not limited to asthma, rhinitis, anaphylaxis, urticaria, atopic dermatitis, food allergy, and stinging insect allergy are exceedingly common in the pediatric population. The impact that these disorders have on health, educational and social activities and costs of medical care are profound and widespread. In order to understand disease and improve therapy, the study of pediatric allergy is justifiably an important health priority and the goal of this protocol. This purpose will be fostered through the following objectives: 1) To gather a database of clinical and immunological data and to better clinically and immunologically characterize disease onset, progression and remittance of these disorders; 2) provide a necessary cohort of pediatric patients for residents in the NIH Clinical Center/NIAID Allergy and Immunology training program and 3) foster collaborative studies in pediatric allergic disease with other institutions. Up to 300 new patients will be enrolled to attain these goals. Patients will undergo screening history, physical examination, and clinical laboratory evaluation according to the standard of practice in the community. Although imaging studies and tissue biopsies will be performed only when clinically indicated, blood samples for cellular and biochemical studies may be collected for research purposes. Treatment plans will be individualized for each patient and the number and length of additional visits and diagnostic evaluations will vary accordingly. Standard immunotherapy for allergic disease may be offered. Through the assessment, analysis, and treatment of a large cohort of patients, we will better understand disease manifestations, trends, outcomes, and mechanisms of pediatric allergy and lay the groundwork for discovery of new therapeutic modalities.
Ages Eligible for Study: | 3 Months to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Males and females, age 3 months to 19 years old, (less than 18 yo).
Individuals referred to the NIH with a diagnosis of asthma, rhinitis, anaphylaxis, urticaria, atopic dermatitis, food allergy, stinging insect allergy or other allergic/inflammatory diseases.
Subjects must maintain a private physician for protocol related and non-related long-term follow-up and for any emergency medical treatment required.
INCLUSION CRITERIA FOR PARENTS:
Must be biological Parent
Must have a child with a diagnosis of allergic disease
EXCLUSION CRITERIA:
Inability to provide informed consent or assent. In the case of minors, unavailability of a parent or guardian.
EXCLUSION CRITERIA FOR PARENTS:
Non-biological parent
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 050084, 05-I-0084 |
Study First Received: | January 29, 2005 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00102570 |
Health Authority: | United States: Federal Government |
Pediatric Atopic Asthma Rhinitis Outpatient Allergy Pediatric Allergy |
Asthma Food Allergy Stinging Insect Allergy Atopic Dermatitis Insect Sting Rhinitis |
Food Hypersensitivity Hypersensitivity Dermatitis, Atopic Hypersensitivity, Immediate |
Asthma Rhinitis Dermatitis |
Immune System Diseases |