Clinical and Immunological Evaluation of Children With Allergies

NCT00102570 | Completed

• 2 other identifiers: 05008405-I-0084
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypersensitivity, Immediate

Keywords

Pediatric; Atopic; Asthma; Rhinitis; Outpatient; Allergy; Pediatric Allergy; Food Allergy; Stinging Insect Allergy; Atopic Dermatitis; Insect Sting

Eligibility Criteria

• Age: 3 Months - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Must be biological Parent
• Must have a child with a diagnosis of allergic disease

You may not qualify if:

• Inability to provide informed consent or assent. In the case of minors, unavailability of a parent or guardian.
• Non-biological parent

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Stone KD. Atopic diseases of childhood. Curr Opin Pediatr. 2003 Oct;15(5):495-511. doi: 10.1097/00008480-200310000-00009.

  PMID: 14508299 BACKGROUND

• 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.

  PMID: 9360747 BACKGROUND

• 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.

  PMID: 12603707 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity, Immediate; Asthma; Rhinitis; Hypersensitivity; Food Hypersensitivity; Dermatitis, Atopic; Insect Bites and Stings

Condition Hierarchy (Ancestors)

Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Respiratory Tract Infections; Infections; Nose Diseases; Otorhinolaryngologic Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 29, 2005
• First Posted: January 31, 2005
• Study Start: January 26, 2005
• Study Completion: August 10, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-08-10

Locations

US (1)