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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 December 2012
• Main ID: NCT00466596
• Date of registration: 25/04/2007
• Primary sponsor: University of North Carolina, Chapel Hill
• Public title: Effect of House Dust Mite Allergen Challenge in Persons Using 1200 mg Gamma Tocopherol Supplements MiteE
• Scientific title: Effect of House Dust Mite Allergen Challenge in Persons Using 1200 mg Gamma Tocopherol Supplements
• Date of first enrolment: March 2007
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00466596
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: David B Peden, MS/MD
• Affiliation: Center for Environmental Medicine, Asthma and Lung Biology

• Name: Michellle Hernandez, MD
• Affiliation: University of North Carolina

Key inclusion & exclusion 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.

-



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Allergic Rhinitis

Mild Asthma

Intervention(s)

Drug: Gamma Tocopherol

Primary Outcome(s)

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]

Secondary Outcome(s)

(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]

Secondary ID(s)

06-0768

Source(s) of Monetary Support

Please refer to primary and secondary sponsors