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.
Condition: Healthy Participants; Tobacco Smokers
MeSH terms: Inflammation
Intervention: Der f
Intervention description: Nasal administration of Dermatophagoides farinae with 100 allergen units (AU), 500 AU, and finally 1000 AU
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: E-cig smokers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Specific allergy to house dust mite D. farinae confirmed by positive immediate skin
             test response

          2. Subjects will either be non-asthmatic or have mild asthma characterized by an Forced
             expiratory volume in one second (FEV1) of at least 80% of predicted to Forced vital
             capacity (FVC) ratio of at least .75

          3. Subjects will be classified as tobacco smokers, e-cigarette users, or non-smokers
             according to the following guidelines.

          4. Ability to withhold antihistamine medications for one week prior to baseline and
             allergen challenge visits

          5. Subjects must be able and willing to give informed consent.

        Exclusion Criteria:

          1. Any chronic medical condition considered by the PI as a contraindication to the
             allergen challenge study including significant cardiovascular disease, diabetes
             requiring medication, chronic renal disease, bleeding disorder, or chronic thyroid
             disease.

          2. Physician directed emergency treatment for an asthma exacerbation within the preceding
             12 months.

          3. Use of systemic steroid therapy within the preceding 12 months for treatment of an
             asthma exacerbation.

          4. Use of inhaled or nasal steroids, cromolyn or leukotriene receptor antagonists
             (Montelukast or zafirlukast ) within the past month (except for use of cromolyn
             exclusively prior to exercise).

          5. Subjects who smoke marijuana or use illicit drugs will be excluded.

          6. Use of daily theophylline within the past month.

          7. Use of nasal medications that might alter the response to nasal allergen challenge
             including anti-inflammatory and anti-histamine agents within one week of challenge.

          8. Inability to withhold inhaled or oral bronchodilator medications for 12 hours prior to
             allergen challenge.

          9. Pregnancy or nursing a baby.

         10. Women of child-bearing age who are not using dependable contraception (such as birth
             control pills, intrauterine device (IUD), estrogen patches) or who are not completely
             abstinent.

         11. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a
             clearly recognized viral induced asthma exacerbation) which would be characteristic of
             a person of moderate or severe persistent asthma as outlined in the current NHLBI
             guidelines for diagnosis and management of asthma.

         12. Exacerbation of asthma more than 2x/week which would be characteristic of a person
             with moderate or severe persistent asthma as outlined in the current NHLBI guidelines
             for diagnosis and management of asthma.

         13. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest
             tightness) which would be characteristic of a person of moderate or severe persistent
             asthma as outlined in the current NHLBI guidelines for diagnosis and management of
             asthma. (Not to include prophylactic use of albuterol prior to exercise).

         14. Viral upper respiratory tract infection or other acute inflammatory conditions of the
             nose or paranasal sinuses, such as sinusitis, within 4 weeks of challenge.

         15. Any acute infection requiring antibiotics within 4 weeks of challenge.

         16. Participating in an allergen inhalation study within 2 weeks of this challenge or use
             of any other investigational agent within the last 30 days.

         17. Use of tricyclic antidepressants or beta-blockers.

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