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NCT03023397 · ClinicalTrials.gov registry record · Phase 1

Evaluation of the Effect of a Nasal Allergen Challenge With Dermatophagoides Farinae Extract on Nasal Airway Inflammation in Allergic Individuals, Comparing E-cigarette Users to Cigarette Smokers and Non-smokers.

A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

Terminated
Registry status
Phase 1
Development phase
12
Enrollment target

NCT03023397: Clinical Trial Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

NCT03023397 is a Phase 1 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03023397, a Phase 1 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.

TERMINATED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation following nasal application of Dermatophagoides farinae (Der f), or house dust mite, extract in e-cigarette users, cigarette smokers, and non-smokers.

Primary Outcome

NLF will be collected immediately prior to administration of the nasal allergen challenge and 4 hours after completion of nasal allergen challenge. The protocol was amended to replace this outcome using Eosinophilic Cationic Protein (ECP) in Nasal Epithelial Lining Fluid (NELF).

Interventions

  • BIOLOGICAL Der f

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2017-03-27
Est. Completion 2018-04-23
Phase Phase 1

Why NCT03023397 stopped before completion

NCT03023397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which Der f is the first listed.

NCT03023397 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03023397 about?

NCT03023397 is a clinical study titled "Evaluation of the Effect of a Nasal Allergen Challenge With Dermatophagoides Farinae Extract on Nasal Airway Inflammation in Allergic Individuals, Comparing E-cigarette Users to Cigarette Smokers and Non-smokers.". The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation following nasal application of Dermatophagoides farinae (Der f), or house dust mite, extract in e-cigarette users, cigarette smokers, and non-smokers.

What is the current status of trial NCT03023397?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-03-27. Estimated completion is 2018-04-23.

What interventions are being tested in trial NCT03023397?

The interventions under investigation include: Der f (BIOLOGICAL).

Who is sponsoring clinical trial NCT03023397?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03023397's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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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Source: ClinicalTrials.gov NCT03023397, the US trial registry maintained by the National Library of Medicine. NCT03023397 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.