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Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma
NCT00001909 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001909
The ClinicalTrials.gov registry entry for NCT00001909 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00001909 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00001909?
The interventions under investigation include: Soluble recombinantly produced IL-4R (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00001909?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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