NCT03031145

Investigation of the Impact of Smoking Status on Allergen-induced Nasal Airway Inflammation Using a Cat Hair (Felis Domesticus) Extract Nasal Allergen Challenge Model

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation following nasal application of felis domesticus, or cat, extract in e-cigarette users, cigarette smokers, and non-smokers.

Detailed description

The recent increase in popularity of e-cigarettes for smoking cessation or in combination with conventional cigarettes has let to safety concerns regarding their potential role in respiratory disease. These tobacco alternatives devices were initially perceived as a "safer" alternative to cigarettes and were marketed without much known about their health effects. Increasing evidence that while they contain fewer toxins and carcinogens than conventional cigarettes, they do involve delivery of ultrafine particles to the lower airways and can contain heavy metals and other chemicals. Tobacco Smoke may augment allergic inflammation resulting from allergic rhinitis and/or asthma. Animal models of allergic asthma demonstrate aggravation of allergen -induced airway inflammation following inhalation of e-cig cartridge solution, with increased airway eosinophil infiltration, production of Th2 cytokines, and airway hyperresponsivness. In vitro studies in human tissues have demonstrated pro-inflammatory responses in a similar way as tobacco smoke, yet a head-to-head comparison of the effects of these two exposures has not been performed in humans. Use of tobacco products remains a pervasive problem in our society and around the world, with significant impact on respiratory health and quality of life. With the emergence of new non-tobacco based nicotine products like e-cigarettes, it is important to understand the impact these substances have on respiratory health and disease. The aim o f this study is to study the impact of these products on allergic inflammation in cat allergic subjects who already routinely use e-cigarettes and to compare their response to those of cigarette smokers and non-smokers. A thorough understanding of the potential health impacts of tobacco alternative substances in seeded, especially given the rising popularity of such products with adolescents and young adults to whom these substances have particular appeals given the purported safety: and variety of flavors to chose from.

Conditions

• Tobacco Smoking
• Healthy Participants
• E-cigarette Smokers

Interventions

Type	Name	Description
BIOLOGICAL	Felis Domesticus	Nasal Administration of Felis Domesticus

Timeline

• Start date: 2017-04-03
• Primary completion: 2017-12-04
• Completion: 2017-12-04
• First posted: 2017-01-25
• Last updated: 2021-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study