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Evaluation and Long-Term Follow-Up of Patients With Allergic and Inflammatory Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00557895
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2007
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

This study will evaluate and follow patients with various allergic, hypersensitivity and inflammatory disorders. The protocol is not designed to test new treatments; patients will be managed with standard of care therapies. Participants may be referred to other current NIAID protocols as appropriate or to new studies as they are developed, but will not be required to join another study.

Patients with allergic, hypersensitivity or inflammatory disorders between the ages of 3 years and 80 years may be eligible for this study. Conditions of interest include, but are not limited to, asthma, allergic rhinitis, mastocytosis, atopic dermatitis and food allergy.

Participants will have a medical history and physical examination, plus standard tests for diagnosing and treating their specific disorder. Tests may include routine blood and urine studies, X-rays or other imaging studies, allergy skin tests and lung function tests. Blood samples may be collected for research on immune system cells and other substances involved in immune function. Generally, about 2 to 6 tablespoons will be drawn at a time, but no more than 16 ounces will be collected over a 6-week period.

NIH does not provide emergency medical treatment or treatment for other, unrelated conditions the patient may have. Therefore, patients must maintain a personal physician for these purposes.

Condition or disease
Allergy Asthma Allergic Rhinitis Mastocytosis Atopic Dermatitis Food Allergy

Detailed Description:
Allergic, hypersensitivity and inflammatory disorders, including but not limited to asthma, allergic rhinitis, mastocytosis, atopic dermatitis and food allergy are exceedingly common disorders. The pathogenesis of these various disorders are being investigated under a number of Laboratory of Allergic Diseases clinical research protocols. This protocol is an evaluation and long term follow-up protocol of such disorders, for the purposes of maintaining a group of patients on which LAD investigators draw for our other various protocols. The patients admitted under this protocol also provide training and experience for members of the NIAID Allergy and Immunology fellowship training programs.

Study Design

Study Type : Observational
Actual Enrollment : 288 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation and Long Term Follow-up of Patients With Allergic and Inflammatory Disorders
Study Start Date : August 26, 1996

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. The protocol serves to evaluate and provide long term follow up of patients with allergic, hypersensitivity and inflammatory disorders for the purposes of maintaining a group of patients from which LAD investigators may draw for other protocols ... [ Time Frame: The outcome is assessed over the time the protocol is active as described elsewhere. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Males and females ages 3 years to 80 years.

Allergic, hypersensitivity or inflammatory diseases.

Willingness to participate in clinical protocols when appropriate.

Subjects must maintain a private physician for non-protocol related medical complaints and for emergency medical treatment required for these or other of their disorders.


Unacceptably poor compliance which, in the opinion of the investigator, would interfere with one's ability to study or provide quality medical care for the patient.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557895

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Kelly D Stone, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
More Information

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00557895     History of Changes
Other Study ID Numbers: 960129
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 18, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Peanut Allergy
Eosinophilic Esophagitis
Eosinophilic Gastroenteritis

Additional relevant MeSH terms:
Rhinitis, Allergic
Dermatitis, Atopic
Food Hypersensitivity
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Skin Diseases
Immune System Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type