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

Withdrawn before enrolling · Phase 1

Conditions studied: Tobacco Smoking, Healthy Participants, E-cigarette Smokers

In brief

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.

Key facts

Study ID

NCT03031145

Run by

University of North Carolina, Chapel Hill

People needed

0

Starts

2017-04-03

Expected to finish

2017-12-04

Last updated by the study team

2021-05-07

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females age 18-50 years
• Specific allergy to cat hair Felis domesticus confirmed by positive immediate skin test response
• 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
• Ability to withhold antihistamine medications for one week prior to baseline and allergen challenge visits.
• Subjects must be able and willing to give informed consent.
• Subjects will be classified as tobacco smokers, e-cigarette users, or non-smokers

You may not qualify if…

• 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.
• Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
• Use of systemic steroid therapy within the preceding 12 months for treatment of an asthma exacerbation.
• 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).
• Use of allergen immunotherapy.
• Use of daily theophylline within the past month.
• 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.
• Inability to withhold inhaled or oral bronchodilator medications for 12 hours prior to allergen challenge.
• Pregnancy or nursing a baby.
• 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.
• 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.
• 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.
• 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).
• Viral upper respiratory tract infection within 4 weeks of challenge.
• Any acute infection requiring antibiotics within 4 weeks of challenge.
• Participating in an allergen inhalation study within 2 weeks of this challenge or use of any investigational agent within the last 30 days.
• Use of tricyclic antidepressants or beta-blockers.
• Use of MAO inhibitors or any medications known to interfere with the treatment of anaphylaxis.
• Subjects with a history of immunologic disease or undergoing immune suppression for cancer or other diseases.
• Subjects with acute inflammatory conditions in the nose or paranasal sinuses, such as sinusitis.

Where it is running

• UNC Center for Environmental Medicine, Asthma and Lung Biology — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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