- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00102570
Clinical and Immunological Evaluation of Children With Allergies
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).
- Pulmonary function test: This test evaluates lung function. The patient blows hard into a tube attached to a machine to measure the airflow from the lungs. At home, the patient uses a small plastic device called a peak flow meter to measure lung function. Patients whose lung function measures less than 80 percent the value predicted for his or her age may be given the medicine albuterol to see if lung function improves.
- Skin prick testing: Drops of up to 55 different allergens (foreign substances, such as pollen and certain foods or medicines that cause reactions like sneezing, hives, eczema, and others) are placed on the back or arm. The skin under the allergen is then scratched with a pointed tool. If the person is allergic, the skin around the scratch develops a small area of itching, redness, or swelling that goes away after 30 to 60 minutes.
- Acoustic rhinometry: To learn the effect of allergies on the size of the nasal cavity, the nasal canal size is measured by placing a small round probe on the nostril. The device sends out and receives a sound wave signal from which the size of the nasal canal is calculated, recorded and stored graphically on a computer screen. The procedure is repeated three times with each nostril.
- Computerized assessment of learning and mood: Patients who are age 10 or older may take this computer test to find out if allergies affect learning and mood. The test measures the child's ability to understand directions, solve problems, and remember things. It also includes questions about how the child feels in general.
- Behavioral assessment system for children: Patients who are age 8 or older may take this true/false questionnaire to assess mood.
- Blood may be drawn for the following purposes: in lieu of skin prick testing to determine sensitivity to allergens; to look for reasons for the severity or cause of an allergy; for research studies on the immune system, including markers of allergy; for genetic tests to determine inherited factors that increase the risk of developing allergies.
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
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
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
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Stone KD. Atopic diseases of childhood. Curr Opin Pediatr. 2003 Oct;15(5):495-511. doi: 10.1097/00008480-200310000-00009.
- Juniper EF. Quality of life in adults and children with asthma and rhinitis. Allergy. 1997 Oct;52(10):971-7. doi: 10.1111/j.1398-9995.1997.tb02416.x.
- Weinmann S, Kamtsiuris P, Henke KD, Wickman M, Jenner A, Wahn U. The costs of atopy and asthma in children: assessment of direct costs and their determinants in a birth cohort. Pediatr Allergy Immunol. 2003 Feb;14(1):18-26. doi: 10.1034/j.1399-3038.2003.02085.x.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 050084
- 05-I-0084
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypersensitivity, Immediate
-
Mahidol UniversityCompletedImmediate HypersensitivityThailand
-
National Institute of Allergy and Infectious Diseases...Consortium of Food Allergy ResearchCompletedHypersensitivity | Food Hypersensitivity | Immediate HypersensitivityUnited States
-
Mahidol UniversityCompletedImmediate HypersensitivityThailand
-
Chulalongkorn UniversityCompleted
-
Centre Hospitalier Régional Metz-ThionvilleCompleted
-
National Institute of Allergy and Infectious Diseases...Consortium of Food Allergy ResearchCompletedHypersensitivity | Food Hypersensitivity | Peanut Hypersensitivity | Immediate HypersensitivityUnited States
-
Johns Hopkins UniversityCompletedFood Hypersensitivity | Peanut Hypersensitivity | Immediate HypersensitivityUnited States
-
Allertein Therapeutics, LLCConsortium of Food Allergy ResearchCompletedHypersensitivity | Food Hypersensitivity | Peanut Hypersensitivity | Immediate HypersensitivityUnited States
-
University of ZurichRecruitingHypersensitivity, FoodSwitzerland
-
Nutricia Nutrition CliniqueCompletedMilk HypersensitivityFrance