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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.

NCT03023397 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-06-04

Study results available
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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.

Conditions

  • Healthy Participants
  • Tobacco Smokers

Interventions

BIOLOGICAL

Der f

Nasal administration of Dermatophagoides farinae with 100 allergen units (AU), 500 AU, and finally 1000 AU

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Michelle Hernandez, MD · University of North Carolina

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-27
Primary Completion
2018-04-16
Completion
2018-04-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03023397 on ClinicalTrials.gov