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NCT03031145 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 16-1686
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Smoking; Healthy Participants; E-cigarette Smokers

Outcome Measures

Primary Outcomes (1)

• Change in eosinophils/mL in nasal lavage fluid (NLF)

  NLF will be collected immediately prior to administration of the nasal allergen challenge. 4 hours after administration of a bolus provocative dose of allergen (determined at screening day visit nasal allergen challenge), NLF will be collected. Pre- and 4 hours post-challenge NLF will be analyzed for cellularity. Values will be compared across e-cigarette smokers, tobacco cigarette smokers, and non-smokers.

  Pre- and 4 hours post- nasal allergen challenge

Secondary Outcomes (2)

• Nasal lavage fluid cytokines

  Pre- and 4 hours post- nasal allergen challenge

• Nasal epithelial cell messenger ribonucleic acid (mRNA)

  Baseline (within two months of nasal allergen challenge) and 4 hours post- nasal allergen challenge

Study Arms (3)

Felis Domesticus treated Non-smoker

ACTIVE COMPARATOR

Biological: Felis Domesticus

Felis Domesticus treated E-cigarette smoker

ACTIVE COMPARATOR

Biological: Felis Domesticus

Felis Domesticus treated Cigarette smoker

ACTIVE COMPARATOR

Biological: Felis Domesticus

Interventions

Felis Domesticus BIOLOGICAL

Nasal Administration of Felis Domesticus

Also known as: Cat Allergen

Felis Domesticus treated Cigarette smoker; Felis Domesticus treated E-cigarette smoker; Felis Domesticus treated Non-smoker

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599-7310, United States

Location

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Study Officials

• Michelle Hernandez, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2017
• First Posted: January 25, 2017
• Study Start: April 3, 2017
• Primary Completion: December 4, 2017
• Study Completion: December 4, 2017
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)