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.

Stopped early · Phase 1

Conditions studied: Healthy Participants, Tobacco Smokers

In brief

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.

Key facts

Study ID

NCT03023397

Run by

University of North Carolina, Chapel Hill

People needed

12

Starts

2017-03-27

Expected to finish

2018-04-23

Last updated by the study team

2021-06-04

Who can join

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

You may qualify if…

• Specific allergy to house dust mite D. farinae confirmed by positive immediate skin test response
• 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
• Subjects will be classified as tobacco smokers, e-cigarette users, or non-smokers according to the following guidelines.
• 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.

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 zafirlukast ) within the past month (except for use of cromolyn exclusively prior to exercise).
• Subjects who smoke marijuana or use illicit drugs will be excluded.
• 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, intrauterine device (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 or other acute inflammatory conditions of the nose or paranasal sinuses, such as sinusitis, 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 other investigational agent within the last 30 days.
• Use of tricyclic antidepressants or beta-blockers.

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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