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NCT02388997 · ClinicalTrials.gov registry record · Phase 2
Treatment With Omalizumab to Improve the Asthmatic Response to Rhinovirus Experimental Infection With Rhinovirus
A Phase 2 study of Asthma, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT02388997: Completed Phase 2 study of Asthma, sponsored by University of Virginia.
NCT02388997 is a Phase 2 study of Asthma that has completed, run by University of Virginia. The registered enrollment target is 31 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02388997, a Phase 2 study of Asthma, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
Population surveys have shown a positive correlation between increased levels of total serum immunoglobulin E (IgE) and bronchial hyperreactivity. However, it is also clear that exacerbations of asthma are frequently triggered by viral respiratory tract infections, especially those caused by human rhinovirus (RV), also known as the "common cold" virus. This protocol explores the relationship between rhinovirus and allergen/IgE provoked inflammation. Experimental challenges with human (RV) result in more persistent upper respiratory tract symptom scores in asthmatics than in controls. Asthmatics with high levels of IgE also show greater sensitivity to methacholine and higher levels of expired nitric oxide (eNO) than those with low levels of IgE. These data suggest that patients with asthma and high levels of IgE are more likely to have pre-existing inflammation of the airways before virus challenge. This study is being done to determine whether anti-IgE therapy (with omalizumab) will lead to a significant decline in inflammatory biomarkers prior to virus inoculation, and thus reduce the severity of clinical manifestations after an experimental human RV challenge.
Primary Outcome
The primary outcome was based on the comparison of cumulative lower respiratory tract symptoms scores (CLRTS) in the asthmatic subjects treated with omalizumab compared to those treated with placebo over the first 4 days of acute infection. The symptoms evaluated daily included wheeze, chest tightness, and shortness of breath. Symptom scores were recorded by subjects twice daily (in the morning and evening). Each symptom was scored on a scale of 1 to 3. Therefore, the total maximum (worst) score
Conditions Studied
Interventions
- DRUG omalizumab
- BIOLOGICAL Rhinovirus (strain 16)
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-02-01 |
| Est. Completion | 2017-05-04 |
| Phase | Phase 2 |
What the finished NCT02388997 record still lists
NCT02388997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which omalizumab is the first listed.
NCT02388997 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT02388997 about?
NCT02388997 is a clinical study titled "Treatment With Omalizumab to Improve the Asthmatic Response to Rhinovirus Experimental Infection With Rhinovirus". Population surveys have shown a positive correlation between increased levels of total serum immunoglobulin E (IgE) and bronchial hyperreactivity. However, it is also clear that exacerbations of asthma are frequently triggered by viral respiratory tract infections, especially those caused by human r...
What is the current status of trial NCT02388997?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2013-02-01. Estimated completion is 2017-05-04.
What conditions does trial NCT02388997 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT02388997?
The interventions under investigation include: omalizumab (DRUG), Rhinovirus (strain 16) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02388997?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02388997 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02388997's enrollment target sits among peer trials
31 301st of 374 higher than 71 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.
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