Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03031145
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Withdrawn
Phase Phase 1
Start date April 3, 2017
Completion date December 4, 2017

See also
  Status Clinical Trial Phase
Completed NCT05445440 - A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine Phase 1
Completed NCT03712540 - An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants Phase 1
Completed NCT03649165 - A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants Phase 1
Completed NCT05956002 - A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants Phase 1
Completed NCT05539976 - A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants
Withdrawn NCT04558216 - Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants Phase 1
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT06097390 - A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III Phase 1
Completed NCT05546151 - A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent Phase 1
Completed NCT05056246 - Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants Phase 1
Completed NCT04390776 - Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules. Phase 1
Completed NCT05074459 - A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines Phase 1
Enrolling by invitation NCT06089109 - Creating VIP Corps to Reduce Maternal Deaths N/A
Completed NCT05996250 - Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects N/A
Completed NCT03278080 - Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1 N/A
Completed NCT05064800 - PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants Phase 1
Completed NCT04471298 - A Study of Qishenyiqi Dripping Pills in Healthy Participants Phase 1
Completed NCT04914936 - A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196 Phase 1
Completed NCT02882386 - Amino Acid Kinetics in Blood After Consuming Different Milk Protein Supplements N/A
Completed NCT01681186 - A Study of LY2940680 in Healthy Participants Phase 1