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| Sponsor: | The University of North Carolina, Chapel Hill |
|---|---|
| Information provided by: | The University of North Carolina, Chapel Hill |
| 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 |
| 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 2009 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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| United States, North Carolina | |
| Center for Environmental Medicine, Asthma and Lung Biology | |
| Chapel Hill, North Carolina, United States, 27599-7310 | |
| 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
| Responsible Party: | Center for Environmental Medicine, Asthma and Lung Biology and Pediatrics ( Ceila E. Loughlin, MD ) |
| Study ID Numbers: | 06-0768 |
| Study First Received: | April 25, 2007 |
| Last Updated: | March 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00466596 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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allergic rhinitis mild asthma dust mite allergy gamma tocopherol |
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Antioxidants Bronchial Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Rhinitis Tocopherols Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Infections Respiratory Tract Diseases Vitamins Tocotrienols Micronutrients Gamma-Tocopherol |
Tocopherol acetate Otorhinolaryngologic Diseases Immune System Diseases Growth Substances Asthma Protective Agents Nose Diseases Pharmacologic Actions Alpha-Tocopherol Vitamin E Lung Diseases Hypersensitivity, Immediate Respiratory Hypersensitivity |