Hypersensitivity, ImmediateNCT00102570
Clinical and Immunological Evaluation of Children With Allergies
An observational study of Hypersensitivity, Immediate, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 19 years
- Conditions the study is for
- Hypersensitivity, Immediate
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2005to 10 Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Inability to provide informed consent or assent. In the case of minors, unavailability of a parent or guardian.
- Non-biological parent
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Hypersensitivity, Immediate
- Keywords
- Pediatric, Atopic, Asthma, Rhinitis, Outpatient, Allergy, Pediatric Allergy, Food Allergy, Stinging Insect Allergy, Atopic Dermatitis, Insect Sting
- Medical subject headings
- Hypersensitivity, Immediate, Asthma, Rhinitis, Hypersensitivity, Food Hypersensitivity, Dermatitis, Atopic, Insect Bites and Stings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2005 (estimated)
- Study start26 Jan 2005
- Study completion10 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypersensitivity, ImmediateStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102570
- Sponsor's protocol ID
- 050084
- Other IDs
- 05-I-0084
- Status last verified
- 10 Aug 2010
- First submitted
- 29 Jan 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Stone KD. Atopic diseases of childhood. Curr Opin Pediatr. 2003 Oct;15(5):495-511. doi: 10.1097/00008480-200310000-00009.
PubMed 14508299Juniper 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.
PubMed 9360747Weinmann 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.
PubMed 12603707
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Immunological Evaluation of Children With Allergic Disease
- ClinicalTrials.gov ID
- NCT00102570
- Acronym / sponsor ID
- 050084
- Conditions
- Hypersensitivity, Immediate
- Keywords
- Pediatric, Atopic, Asthma, Rhinitis, Outpatient, Allergy, Pediatric Allergy, Food Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 26 Jan 2005
- Study completion
- 10 Aug 2010
- First posted
- 31 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
Who may qualify
- Ages
- 3 months to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to provide informed consent or assent. In the case of minors, unavailability of a parent or guardian.
- Non-biological parent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 14508299Stone KD. Atopic diseases of childhood. Curr Opin Pediatr. 2003 Oct;15(5):495-511. doi: 10.1097/00008480-200310000-00009.
- Background: PubMed 9360747Juniper 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.
- Background: PubMed 12603707Weinmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity, Immediate, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00102570, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.