Effect of House Dust Mite Allergen Challenge in Persons Using 1200 mg Gamma Tocopherol Supplements

NCT00466596 | Completed Phase 1

• 1 other identifier: 06-0768
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis; Mild Asthma

Keywords

allergic rhinitis; mild asthma; dust mite allergy; gamma tocopherol

Outcome Measures

Primary Outcomes (1)

• Post-treatment change in concentration of house dust mite-induced eosinophils in nasal lavage fluid (NLF), compared to pre-treatment baseline.

  4 hours

Secondary Outcomes (1)

• (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

  1 week

Interventions

Gamma Tocopherol DRUG

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.

Also known as: gT, Vitamin E, Tocopherol, Vitamin

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 Dermatophagoides farinae confirmed by positive immediate skin test response.
• Subjects may be enrolled with mild asthma if an FEV1 of at least 80% of predicted and
• 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
• Ability to withhold antihistamine medications for one week prior to study and one week prior to each nasal challenge visit.
• 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 inhibitors (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 bronchodilating 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 or estrogen patches) or who are not completely abstinent.
• Cigarette smoking within the past 12 months of more than 1 pack/week.
• 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 2 weeks of challenge.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Center for Environmental Medicine, Asthma and Lung Biology

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

Location

Related Links

• Center for Environmental Medicine, Asthma and Lung Biology

MeSH Terms

Conditions

Rhinitis, Allergic; Dust Mite Allergy

Interventions

gamma-Tocopherol; Vitamin E; Tocopherols; Vitamins

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic, Perennial

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Michellle Hernandez, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• David B Peden, MS/MD

  Center for Environmental Medicine, Asthma and Lung Biology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

US (1)