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T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma Clinical research trials and T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma. T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma clinical trial. Human subjects often receive the most effective healthcare possible for their T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma  T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma
T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma
For Condition: Asthma,Hypersensitivity
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow obstruction. Fourteen million people (6.4%) in the United States report having asthma, and from 1980 to 1994 the prevalence of self-reported asthma in the United States increased 75%. Interleukin-4 (IL-4) plays a key role in this response by promoting IgE production, upregulating IgE receptors, upregulating adhesion receptors such as VCAM-1, promoting Th2 cell development and promoting mucus secretion. A soluble form of the receptor for IL-4 (IL-4R) that has antagonist activity has been developed for clinical use. Soluble IL-4R acts by competing with endogenous cell bound IL-4R for free IL-4, thus inhibiting IL-4 function. IL-4 is required for the development of allergen specific Th2 memory cells. Less well understood are the factors required for maintenance of Th2 responses. The maintenance of polarized Th2 responses to allergens have been postulated to require IL-4 itself, by acting as an anti-apoptotic/survival factor or by differentiating naive allergen specific T cells to the Th2 phenotype. Subjects on sIL-4 therapy represent a unique patient group that possess allergen specific Th2 cells, but in which the capacity for IL-4 to promote further Th2 cell survival or differentiation has been blocked. This is a single site adjunct study proposed to study subjects ages 14 years and older who are enrolled at the NIH Clinical Center on a multicenter trial of IL-4R in moderate to severe asthma (Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma). A maximum of 40 subjects will be enrolled. We hypothesize that effective blocking of such Th2 priming would result in a decreased frequency of both allergen specific Th2 cells as well as mitogen activated Th2 cells. Determination of the fate of Th2 cell responses during long term IL-4R therapy may have important implications both for future development of anti-cytokine therapies as well as for understanding the T cell biology of allergic diseases and asthma.
Details: Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow obstruction. Fourteen million people (6.4%) in the United States report having asthma, and from 1980 to 1994 the prevalence of self-reported asthma in the United States increased 75%. Interleukin-4 (IL-4) plays a key role in this response by promoting IgE production, upregulating IgE receptors, upregulating adhesion receptors such as VCAM-1, promoting Th2 cell development and promoting mucus secretion. A soluble form of the receptor for IL-4 (IL-4R) that has antagonist activity has been developed for clinical use. Soluble IL-4R acts by competing with endogenous cell bound IL-4R for free IL-4, thus inhibiting IL-4 function. IL-4 is required for the development of allergen specific Th2 memory cells. Less well understood are the factors required for maintenance of Th2 responses. The maintenance of polarized Th2 responses to allergens have been postulated to require IL-4 itself, by acting as an anti-apoptotic/survival factor or by differentiating naive allergen specific T cells to the Th2 phenotype. Subjects on sIL-4 therapy represent a unique patient group that possess allergen specific Th2 cells, but in which the capacity for IL-4 to promote further Th2 cell survival or differentiation has been blocked. This is a single site adjunct study proposed to study subjects ages 14 years and older who are enrolled at the NIH Clinical Center on a multicenter trial of IL-4R in moderate to severe asthma (Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma). A maximum of 40 subjects will be enrolled. We hypothesize that effective blocking of such Th2 priming would result in a decreased frequency of both allergen specific Th2 cells as well as mitogen activated Th2 cells. Determination of the fate of Th2 cell responses during long term IL-4R therapy may have important implications both for future development of anti-cytokine therapies as well as for understanding the T cell biology of allergic diseases and asthma.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients must be 14 years of age or older. Must be participating in 99-I-0115 "Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma". If younger than 18 years old, must weigh 50 kg or more. Must have HIV seronegativity. Must not have hemoglobin less than 12 g/dL.
Total Enrollment: 40
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990114; 99-I-0114
Study Start Date: June 2, 1999
Record last reviewed: July 18, 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001908
Other Asthma Studies:
1. Controlling Asthma at School
2. Isocyanate Antigens and T Cells That Cause Asthma
3. Prospective Evaluation of Airways Reactivity
4. Asthma Clinical Research Network (ACRN)
5. FLASH Study: A study of roflumilast versus placebo in patients with asthma
Related Studies:
Other Asthma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma
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