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| 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 |
| 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 |
| 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) |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects with a history of immunologic disease or undergoing immune suppression for cancer or other diseases.
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Contacts and Locations| 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 |
| 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 | |||||
| University of North Carolina |
| 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 
  |
| 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 |
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