ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Effect of House Dust Mite Allergen Challenge in Persons Using 1200 mg Gamma Tocopherol Supplements (MiteE)

This study is currently recruiting participants.
Verified by University of North Carolina, April 2008

Sponsored by: University of North Carolina
Information provided by: University of North Carolina
ClinicalTrials.gov Identifier: NCT00466596
  Purpose

Twenty, house dust mite (HDM)-allergic non-smoking subjects with or without mild asthma between the ages 18-50 will be recruited. The primary endpoint will be nasal eosinophilia. Each volunteer will be screened with skin testing, pulmonary function testing and induced sputum. If eligible they will return for baseline nasal allergen challenge and lavage. Approximately two weeks later they will return for gamma tocopherol (gT) dosing visit. After completing 14 days of daily high dose (1200mg) gT, they will return for a second nasal allergen challenge. This visit will also include pulmonary function testing and blood draw. The purpose of this study is to determine if high dose gamma tocopherol therapy can reduce allergen induced nasal inflammation.


Condition Intervention Phase
Allergic Rhinitis
Mild Asthma
Drug: Gamma Tocopherol
Phase I

MedlinePlus related topics:   Asthma    Dietary Supplements   

ChemIDplus related topics:   Vitamin E    alpha-Tocopherol    alpha-Tocopheryl acetate    Tocopherols   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Effect of House Dust Mite Allergen Challenge in Persons Using 1200 mg Gamma Tocopherol Supplements

Further study details as provided by University of North Carolina:

Primary Outcome Measures:
  • Post-treatment change in concentration of house dust mite-induced eosinophils in nasal lavage fluid (NLF), compared to pre-treatment baseline. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • (a)NLF inflammatory mediators including eicosanoid products, inflammatory cytokines relevant to innate immunity and allergic inflammation, cells other than eosinophils, total protein (b)safety outcomes of cbc and coagulation factors [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   20
Study Start Date:   March 2007
Estimated Study Completion Date:   November 2008
Estimated Primary Completion Date:   November 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Gamma Tocopherol
    14 days of daily high dose (1200mg) Gamma Tocopherol. Subjects will receive a 14 day supply (28 softgel capsules, approximately 600 grams of gT each) dispensed by the University of North Carolina Hospitals Investigational Drug Service and provided by YASOO Medical.
Show detailed description  Show Detailed Description

  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 an FEV1 of at least 80% of predicted and
  3. FEV1/FVC ratio of at least .70 (without use of bronchodilating 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 by the method used (see below); OR b) physician diagnosed asthma with symptoms and chronic daily therapy consistent with the mild asthma
  4. Ability to withhold antihistamine medications for one week prior to study and one week prior to each nasal challenge visit.
  5. 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, bleeding disorder, 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 Zafirkulast) 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. Inability to withhold inhaled or oral bronchodilating medications for 12 hours prior to allergen challenge.
  9. Pregnancy or nursing a baby.
  10. Women of child-bearing age who are not using dependable contraception (such as birth control pills, IUD or estrogen patches) or who are not completely abstinent.
  11. Cigarette smoking within the past 12 months of more than 1 pack/week.
  12. 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.
  13. 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.
  14. 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).
  15. Viral upper respiratory tract infection within 2 weeks of challenge.
  16. Any acute infection requiring antibiotics within 2 weeks of challenge.
  17. Participating in an allergen inhalation study within 2 weeks of this challenge or use of any investigational agent within last 30 days.
  18. Use of tricyclics or beta-blockers.
  19. Use of MAO inhibitors or any medications known to interfere with the treatment of anaphylaxis.
  20. Subjects with a history of immunologic disease or undergoing immune suppression for cancer or other diseases.

    -

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466596

Contacts
Contact: Ceila E Loughlin, MD     919-966-1055     cloughli@unch.unc.edu    
Contact: Carole A Robinette, MS     919-966-5638     carole_robinette@med.unc.edu    

Locations
United States, North Carolina
Center for Environmental Medicine, Asthma and Lung Biology     Recruiting
      Chapel Hill, North Carolina, United States, 27599-7310
      Contact: Carole A Robinette, MS     919-966-5638     carole_robinette@med.unc.edu    
      Principal Investigator: Ceila E Loughlin, MD            

Sponsors and Collaborators
University of North Carolina

Investigators
Principal Investigator:     Ceila E Loughlin, MD     University of North Carolina    
Study Director:     David B Peden, MS/MD     Center for Environmental Medicine, Asthma and Lung Biology    
  More Information

Center for Environmental Medicine, Asthma and Lung Biology  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Center for Environmental Medicine, Asthma and Lung Biology and Pediatrics ( Ceila E. Loughlin, MD )
Study ID Numbers:   06-0768
First Received:   April 25, 2007
Last Updated:   April 1, 2008
ClinicalTrials.gov Identifier:   NCT00466596
Health Authority:   United States: Food and Drug Administration

Keywords provided by University of North Carolina:
allergic rhinitis  
mild asthma  
dust mite allergy  
gamma tocopherol  

Study placed in the following topic categories:
Tocopherols
Tocopherol acetate
Vitamin E
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hypersensitivity, Immediate
Asthma
Rhinitis
Gamma-Tocopherol
Alpha-Tocopherol

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins
Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on August 27, 2008




Links to all studies - primarily for crawlers