Clinical trial: Investigation of the Impact of Smoking Status on Allergen-induced Nasal Airway Inflammation Using a Cat Hair (Felis Domesticus) Extract Nasal Allergen Challenge Model (NCT03031145)

Eligibility criteria:
Inclusion Criteria:

          1. Males and females age 18-50 years

          2. Specific allergy to cat hair Felis domesticus confirmed by positive immediate skin
             test response

          3. Subjects may be enrolled with mild asthma if a Forced Expiratory Volume in 1 second
             (FEV1) of at least 80% of predicted and a Forced Expiratory Volume in 1 second to
             Forced Vital Capacity (FVC) ratio (FEV1/FVC ratio) of at least .75 (without use of
             bronchodilator medications for 12 hours), consistent with lung function of persons
             with mild episodic or mild persistent asthma is demonstrated. For the purpose of this
             protocol, an asthmatic individual will be defined as having a) positive methacholine
             challenge with a provocative concentration of methacholine producing a 20% fall in
             FEV1 (PC20 methacholine) with less than or equal to 10 mg/ml; OR b) physician
             diagnosed asthma with symptoms and chronic daily therapy consistent with the mild
             asthma

          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.

          6. Subjects will be classified as tobacco smokers, e-cigarette users, or non-smokers

        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 Zafirkulast) within the past month (except for use of cromolyn
             exclusively prior to exercise).

          5. Use of allergen immunotherapy.

          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, 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 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 investigational agent within the last 30 days.

         17. Use of tricyclic antidepressants or beta-blockers.

         18. Use of MAO inhibitors or any medications known to interfere with the treatment of
             anaphylaxis.

         19. Subjects with a history of immunologic disease or undergoing immune suppression for
             cancer or other diseases.

         20. Subjects with acute inflammatory conditions in the nose or paranasal sinuses, such as
             sinusitis.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? 0