Clinical and Immunological Evaluation of Children With Allergies
|First Received Date ICMJE||January 29, 2005|
|Last Updated Date||August 11, 2010|
|Start Date ICMJE||January 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00102570 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Clinical and Immunological Evaluation of Children With Allergies|
|Official Title ICMJE||Clinical and Immunological Evaluation of Children With Allergic Disease|
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).
Patients are scheduled for follow-up visits based on their diagnosis and severity of illness. Most patients return for within one month of their first study visit and then, in general, once a month when allergies are severe, and every few months when they are more stable. Visits include an updated history and physical examination, blood tests, and possibly some of the tests described above. Patients may also have intradermal skin testing, in which allergens that are used for skin prick testing are injected into the forearms or upper arms just below the surface of the skin.
Patients who test positive to allergens may be offered standard treatment with allergy shots.
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) to foster collaborative studies in pediatric allergic disease with other institutions and 3) to provide a cohort of pediatric patients for residents in the NIH Clinical Center/NIAID Allergy and Immunology training program. Up to 500 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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Hypersensitivity, Immediate|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||August 2010|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Males and females, age 3 months to 19 years old, (less than 18 years old).
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 primary 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
Inability to provide informed consent or assent. In the case of minors, unavailability of a parent or guardian.
EXCLUSION CRITERIA FOR PARENTS:
|Ages||3 Months to 19 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00102570|
|Other Study ID Numbers ICMJE||050084, 05-I-0084|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP