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NCT00001909 · ClinicalTrials.gov registry record · Phase 2
Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma
A Phase 2 study of Asthma and Hypersensitivity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00001909: Completed Phase 2 study of Asthma and Hypersensitivity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001909 is a Phase 2 study of Asthma and Hypersensitivity that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 40 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001909, a Phase 2 study of Asthma and Hypersensitivity, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow obstruction. Fourteen million persons (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 by 75%. A major factor in the pathogenesis of asthma is the development of an allergic inflammatory response to inhaled antigens. 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 increasing mucus secretion. Soluble recombinantly produced IL-4R (sIL-4R) has been shown to bind and inactivate IL-4, both in vitro and in animal models. As part of a multicenter trial, 20 subjects at the NIH site will receive 0.9 mg., 1.8 mg. sIL-4R or placebo once weekly for 12 weeks in a double blind placebo controlled study. Study drug will be delivered via the AERx aerosol drug delivery device. The primary objective of the study will be to evaluate efficacy as measured by FEV1. Secondary objectives will include changes in FVC, FEF 27-75, peak flow, bronchodilator usage, asthma symptoms, quality of life scores, immunologic and inflammatory markers, pharmacokinetics, safety and immunogenicity. The study population will consist of moderate to severe asthmatics on (Beta)-agonist monotherapy with an FEV1 of 50-80% of predicted. After 12 weeks of study drug, subjects will be followed for an additional 8 weeks.
Conditions Studied
Interventions
- DRUG Soluble recombinantly produced IL-4R
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 1999-05 |
| Est. Completion | 2000-05 |
| Phase | Phase 2 |
What the finished NCT00001909 record still lists
NCT00001909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which Soluble recombinantly produced IL-4R is the first listed.
NCT00001909 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001909 about?
NCT00001909 is a clinical study titled "Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma". Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow obstruction. Fourteen million persons (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 by 75%. A major factor in t...
What is the current status of trial NCT00001909?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 1999-05. Estimated completion is 2000-05.
What conditions does trial NCT00001909 study?
This clinical trial studies the following conditions: Asthma, Hypersensitivity.
What interventions are being tested in trial NCT00001909?
The interventions under investigation include: Soluble recombinantly produced IL-4R (DRUG).
Who is sponsoring clinical trial NCT00001909?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001909 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001909's enrollment target sits among peer trials
40 282nd of 374 higher than 91 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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