Evaluation and Long-Term Follow-Up of Patients With Allergic and Inflammatory Disorders
|First Received Date ICMJE||November 10, 2007|
|Last Updated Date||January 31, 2013|
|Start Date ICMJE||August 1996|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00557895 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation and Long-Term Follow-Up of Patients With Allergic and Inflammatory Disorders|
|Official Title ICMJE||Evaluation and Long Term Follow-up of Patients With Allergic and Inflammatory Disorders|
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 1 month 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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Inflammatory Disorder|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Prussin C, Lee J, Foster B. Eosinophilic gastrointestinal disease and peanut allergy are alternatively associated with IL-5+ and IL-5(-) T(H)2 responses. J Allergy Clin Immunol. 2009 Dec;124(6):1326-32.e6.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||300|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Males and females ages 1 month 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.
|Ages||1 Month to 80 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00557895|
|Other Study ID Numbers ICMJE||960129, 96-I-0129|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP