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Home > "A" Clinical Trials Conditions > Activation and Function of Eosinophils in Conditions with Blood or Tissue Eosinophilia  Activation and Function of Eosinophils in Conditions with Blood or Tissue Eosinophilia
Activation and Function of Eosinophils in Conditions with Blood or Tissue Eosinophilia
For Condition: Asthma,Eosinophilia,Helminthiasis,Hypersensitivity,Parasitic Disease
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will investigate how, why and under what conditions eosinophils (a type of white blood cell) become activated and will examine their function in immune reactions. Eosinophil counts often rise in response to allergies, asthma, and parasitic worm infections. They can also go up in uncommon autoimmune conditions and, rarely, in association with tumors. Elevated levels of these cells is called eosinophilia. Usually, eosinophilia causes no apparent symptoms, but in rare cases there may be local swelling and itching, allergic lung problems, heart disease or nerve damage caused by the release of toxic substances in these cells into body tissues. Patients 1 to 75 years of age with eosinophil counts greater than 50/ml or an abnormal accumulation of eosinophils in the skin or body tissues may be eligible for this study. All participants will have a thorough medical history, physical examination and blood tests. Depending on the person's age and symptoms, other diagnostic tests may be done, including specialized studies of the eye, lungs, skin, bone marrow, nerves or heart. This is not a treatment study, and no experimental treatments will be offered. Patients who require treatment will receive standard medical care. Certain other procedures may be requested solely for research purposes. All participants will be asked to donate extra blood for laboratory studies investigating how immune cells and other immune substances in the blood act to stimulate a rise in eosinophils. In addition, some participants may undergo one or more of the following: - Follow-up evaluations - Physical examinations and blood tests to evaluate changes in the patient's condition and eosinophil counts over time. - Urine collections to look for products related to eosinophilia. - Leukapheresis (only patients 18 years and older) to collect large numbers of certain cells - In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are then removed and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm. - Bronchoalveolar lavage (only patients 18 years and older) to collect a lung tissue sample - This procedure involves inserting a catheter (flexible tube) into the lungs to instill saline (salt water) and obtain a tissue sample. This test will be done only if medically necessary. - Skin tests to study how the body's immune system learns to react to certain allergens (extracts of things that cause allergy, such as dust, mold, trees grasses weeds, etc.). For these tests, the skin is scratched slightly and an allergen is placed over the broken skin to see if an allergic response occurs. Alternatively, a small amount of allergen is injected just under the skin with a very fine needle and the site is monitored for an allergic reaction.
Details: Patients admitted on this protocol will have elevated eosinophil counts in the peripheral blood or tissues. After thorough clinical evaluation they will be studied in detail immunologically, and their blood cells and/or serum will be collected to provide reagents (e.g., specific antibodies, T-cell clones, etc.) that will be used in the laboratory to address broader questions relating to the etiology of eosinophilia, its immunoregulation, the degree and source of eosinophil activation, and/or the functional role of eosinophils in the afferent arm of those immune response where they are prominent. While the protocol is not primarily designed to study treatment of patients with blood and tissue eosinophilia, the clinical and immunological responses to various medically indicated therapies will be carefully monitored. The patients themselves will be followed over time to determine the kinetics and nature of the factors affecting their degree of eosinophilia and the level of activation or degranulation of the eosinophils at various time points and in response to various stimuli. It is anticipated that the patients will receive a degree of clinical evaluation, care and monitoring more extensive than that generally available and that the specimens collected from them will prove to be valuable reagents for laboratory studies related to eosinophilia, eosinophil activation and function. Recognized causes of patients' hypereosinophilia will be treated appropriately either by our own clinical service or by the referring physicians. Experimental chemotherapy in this protocol is restricted to that administered under special exemption status.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: All patients 1-100 years of age with increases in blood and/or tissue eosinophilia will be eligible for evaluation under this protocol. For bronchoalveolar lavage, only those patients 21 years old or older with acceptable pulmonary function parameters, negative sputum cultures and skin test for TB and no history of allergy to benzodiazipines, atrophine, or local anesthetic will be eligible. No other significant medical problems such as cardiac disease or coagulopathy. Plasmapheresis or leukapheresis will be carried out only on individuals 18 years of age or older. Donor requirements will be similar to those for whole blood donation, with screening performed by both the investigator and the blood bank. EXCLUSION CRITERIA: There should be no clinical contraindications to the procedure (for example, severe anemia, cardiovascular disease, coagulopathy, etc.).
Total Enrollment: 200
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 940079; 94-I-0079
Study Start Date: February 10, 1994
Record last reviewed: February 25, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001406
Other Asthma Studies:
1. Activation and Function of Eosinophils in Conditions with Blood or Tissue Eosinophilia
2. Comparison of Immune Response in Normal Volunteers and Patients with Helminth Infections
3. Host Response to Infection and Treatment in Filarial Diseases
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Activation and Function of Eosinophils in Conditions with Blood or Tissue Eosinophilia
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