Evaluation of a Nasal Allergen Challenge Procedure Using Dust Mite Extract (Dusty)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michelle Hernandez, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00927329
First received: June 22, 2009
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to serve as a pilot safety study for nasal allergen challenges.


Condition Intervention Phase
Dermatophagoides Farinae Allergy
Asthma
Healthy
Biological: dust mite inhalation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of the Safety and Effect of an Allergen Challenge Procedure on Nasal Airway Inflammation in Allergic Individuals Using a Dermatophagoides Farinae Extract Nasal Allergen Challenge Protocol

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Successful nasal allergen challenge without serious adverse event. [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • analyze and compare cells of the airway and serum for a variety of inflammatory markers relevant to innate immunity. [ Time Frame: 4 hr post exposure ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: October 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dust mite Biological: dust mite inhalation
Nasal allergen challenge will be provided in a graded dose fashion of 0 AU, 100 AU, 500 AU, and 1000 AU separated by 20 minutes.
Other Names:
  • allergy
  • allergic
  • Dermatophagoides
  • farinae
  • allergen
  • dust allergy
  • dust
  • mite
  • mite allergy

Detailed Description:

The purpose of this study is to serve as a pilot safety study for the implementation of a new technique for nasal allergen challenges. The new technique consists of having patients maximally inhale to total lung capacity. A nasal metered dose pump will be used to deliver the Dermatophagoides farinae allergen to the nasal mucosa. The patient will not sniff after allergen delivery as in the previous study but instead exhale through the mouth. The investigators propose that this technique will inhibit large amounts of allergen reaching airway mucosa beyond the nasal site of introduction thus limiting serious adverse events.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Specific allergy to house dust mite Dermatophagoides farinae confirmed by positive immediate skin test response.
  2. Subjects may be enrolled with mild asthma if they have an FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without the use of bronchodilating medications for 12 hours). This is consistent with lung function of persons with mild episodic or mild persistent asthma. For the purpose of this protocol, an asthmatic individual will be defined as having: a) 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 by the method used; OR b) physician diagnosed asthma with symptoms and chronic daily therapy consistent with mild asthma.
  3. Ability to withhold antihistamine medications for one week prior to screening visit and one week prior to nasal allergen challenge visit.
  4. Subjects must be able and willing to give informed consent.

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, 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 inhibitors (Montelukast or Zafirlukast) 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. Pregnancy or nursing a baby.
  9. Cigarette smoking within the past 12 months.
  10. 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.
  11. 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.
  12. 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).
  13. Vitamin or herbal supplementation considered by the PI as having anti-inflammatory and/or anti-oxidant properties must be stopped 7 days prior to entrance into the study.
  14. A history of nasal or sinus surgery within the last 5 years.
  15. Viral URI within four weeks of challenge.
  16. Acute infection requiring the use of antibiotics within the last four weeks. Must be off antibiotics for at least two weeks prior to study.
  17. Participation in an allergen challenge study within two weeks of this challenge or use of an investigational agent within the last 30 days.
  18. Use of tricyclic antidepressants, beta-blockers, monoamine oxidase inhibitors or other drugs that may interfere with the treatment of anaphylaxis.
  19. Subjects with history of immunologic disease or on immune suppression for cancer or other disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927329

Contacts
Contact: Carole a Robinette, MS 919-966-5638 carole_robinette@med.unc.edu
Contact: Aline Kala, RN 919-843-9108 akala@unc.unc.edu

Locations
United States, North Carolina
Center for Environmetal Medicine Asthma and Lung Biology Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Carole a Robinette, MS    919-966-5638    carole_robinette@med.unc.edu   
Contact: Martha Almond    919-966-0759    marrt@med.unc.edu   
Principal Investigator: David Peden, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: David Peden, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Michelle Hernandez, MD, Principle Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00927329     History of Changes
Other Study ID Numbers: 09-0196, 59719
Study First Received: June 22, 2009
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:
Dermatophagoides
farinae
allergen
dust
allergic
mite
allergy

Additional relevant MeSH terms:
Hypersensitivity
Asthma
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on August 28, 2014