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NCT00001908 · ClinicalTrials.gov registry record
T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 40
- Enrollment target
NCT00001908: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001908 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001908 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 1999-06 |
| Est. Completion | 2001-07 |
What the finished NCT00001908 record still lists
NCT00001908 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00001908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001908 about?
NCT00001908 is a clinical study titled "T Cell Cytokine Changes During IL-4 Receptor Treatment for Asthma". 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) pl...
What is the current status of trial NCT00001908?
This trial is currently completed. The enrollment target is 40 participants. The study started on 1999-06. Estimated completion is 2001-07.
Who is sponsoring clinical trial NCT00001908?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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