| City: |
|
Bethesda |
|
State:
|
|
MD |
| Zip Code: |
|
20892 |
| Conditions: |
|
Hypersensitivity, Immediate |
| Purpose: |
|
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 summary: |
|
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. |
| Criteria: |
|
- 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 |
|
|
|
|
|
|
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 22, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|