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NCT04901455 · ClinicalTrials.gov registry record · Early Phase 1
Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD)
A Early Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 24
- Enrollment target
NCT04901455: Completed Early Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT04901455 is a Early Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 24 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04901455, a Early Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will determine the functional status of the nasal immune environment with LAIV exposure in COPD persons with frequent exacerbations (defined as individuals with two or more episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months) and COPD persons without frequent exacerbations to determine acute exacerbation of COPD (AECOPD)-associated dysfunction in a) cytokines and immune effector cells of the nasal mucosa and b) viral replication. The investigators hypothesize that: 1) COPD frequent exacerbators, compared to COPD infrequent exacerbators, will demonstrate altered mucosal immune responses to LAIV exposure, and 2) COPD frequent exacerbators, compared to COPD infrequent exacerbators, will demonstrate increased markers of influenza viral replication after LAIV exposure.
Primary Outcome
Epithelial lining fluid interferon-gamma (INF-ɣ) area under the curve (AUC) from day 0 (baseline) to day 3 (pg/mL x days)
Interventions
- BIOLOGICAL LAIV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2026-02-16 |
| Phase | Early Phase 1 |
What the finished NCT04901455 record still lists
NCT04901455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which LAIV is the first listed.
NCT04901455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04901455 about?
NCT04901455 is a clinical study titled "Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD)". This study will determine the functional status of the nasal immune environment with LAIV exposure in COPD persons with frequent exacerbations (defined as individuals with two or more episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months) ...
What is the current status of trial NCT04901455?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2022-10-03. Estimated completion is 2026-02-16.
What interventions are being tested in trial NCT04901455?
The interventions under investigation include: LAIV (BIOLOGICAL).
Who is sponsoring clinical trial NCT04901455?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04901455's enrollment target sits among peer trials
24 1037th of 2000 higher than 914 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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