Hypersensitivity, Immediate Clinical Trial
Official title:
Clinical and Immunological Evaluation of Children With Allergic Disease
Verified date | August 10, 2010 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 270 |
Est. completion date | August 10, 2010 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 19 Years |
Eligibility |
- 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 |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Juniper EF. Quality of life in adults and children with asthma and rhinitis. Allergy. 1997 Oct;52(10):971-7. Review. — View Citation
Stone KD. Atopic diseases of childhood. Curr Opin Pediatr. 2003 Oct;15(5):495-511. Review. — View Citation
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. — View Citation
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