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.

NCT03023397 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 16-1622P50HL120100-05
• Study Type: interventional
• Target: 12
• 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 Dermatophagoides farinae (Der f), or house dust mite, extract in e-cigarette users, cigarette smokers, and non-smokers.

Conditions

Healthy Participants; Tobacco Smokers

Keywords

E-cig smokers

Outcome Measures

Primary Outcomes (2)

• Mean Change in Eosinophils Per mL in Nasal Lavage Fluid (NLF)

  NLF will be collected immediately prior to administration of the nasal allergen challenge and 4 hours after completion of nasal allergen challenge. The protocol was amended to replace this outcome using Eosinophilic Cationic Protein (ECP) in Nasal Epithelial Lining Fluid (NELF).

  Baseline, 4 hours post-allergen challenge

• Mean Change in Eosinophilic Cationic Protein (ECP) Levels in Nasal Epithelial Lining Fluid (NELF)

  NELF will be collected immediately prior to administration of the nasal allergen challenge and 4 hours after completion of nasal allergen challenge.

  baseline, 4 hours post-allergen challenge

Secondary Outcomes (4)

• Mean Change in Interleukin-31 (IL-31) Concentrations in NELF

  Pre- and 4 hours-post nasal allergen challenge

• Mean Change in Interleukin-5 (IL-5) Concentrations in NELF

  baseline, 4 hours post-allergen challenge

• Mean Change in Macrophage Inflammatory Protein 1 Alpha (MIP-1a) Concentration in NELF

  baseline, 4 hours post-allergen challenge

• Mean Change in Macrophage Inflammatory Protein 1 Beta (MIP-1b) in NELF

  baseline, 4 hours post-allergen challenge

Other Outcomes (1)

• Nasal Epithelial Cell Messenger Ribonucleic Acid (mRNA) Expression

  Baseline, 4 hours post- nasal allergen challenge

Study Arms (3)

Der f treated Non-smoker

OTHER

Biological: Der f

Der f treated Cigarette smoker

OTHER

Biological: Der f

Der f treated E-cig user

OTHER

Biological: Der f

Interventions

Der f BIOLOGICAL

Nasal administration of Dermatophagoides farinae with 100 allergen units (AU), 500 AU, and finally 1000 AU

Also known as: (Der f)

Der f treated Cigarette smoker; Der f treated E-cig user; Der f treated Non-smoker

Eligibility Criteria

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

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.

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

Results Point of Contact

• Title: Allison Burbank, MD
• Organization: University of North Carolina at Chapel Hill

allison_burbank@med.unc.edu

919-962-5136

Study Officials

• Michelle Hernandez, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 13, 2017
• First Posted: January 18, 2017
• Study Start: March 27, 2017
• Primary Completion: April 16, 2018
• Study Completion: April 23, 2018
• Last Updated: June 4, 2021
• Results First Posted: June 4, 2021

Record last verified: 2021-05

Locations

US (1)