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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00581048 |
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Date of registration:
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22/12/2007 |
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Primary sponsor: |
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Public title:
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Study on the Role of Treatment With Vitamin E on Asthmatic Responses in Allergic Asthmatics
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Scientific title:
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Oxidant Stress and Allergic Asthma |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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43 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00581048 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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Ryszard Dworski, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Normal health status except for allergic asthma
- Physician diagnosis of mild allergic asthma
- Positive allergen skin tests to common aeroallergens
Exclusion Criteria:
- Use of systemic or high doses of inhaled corticosteroids, >840 mcg of inhaled
beclomethasone of its equivalent (as defined in the consensus report (6))
- Past history of severe asthma (as defined in the consensus report (6))
- History of asthma exacerbation within the past month
- History of recent upper respiratory infection within the past month
- Active immunotherapy for allergic diseases
- Significant disease other than allergic asthma and allergic rhinitis, such as
coronary disease, hypertension, renal failure, anemia, immunodeficiency, cancer,
diabetes
- Present or remote tobacco smoking
- Use of OTC drugs including acetaminophen and pseudoephedrine, herbs, or vitamins
- Psychiatric illness that would make adherence to protocol difficult
- Inability to give informed consent
- Nursing or pregnant women
- Woman planning to become pregnant during the study or not using adequate birth
control methods (barrier or hormonal methods)
- H/o sensitivity to tocopherol-derivatives or medications used during bronchoscopy
- Inability to comply with the research protocol
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Allergic Asthma
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Intervention(s)
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Drug: Natural source d-a-tocopheryl acetate
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Primary Outcome(s)
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The primary outcome will be the difference in allergen stimulated F2-Isoprostanes in BAL and EBC specimens.
[Time Frame: After 16-18 weeks of treatment with vitamin E daily]
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Secondary Outcome(s)
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The secondary outcome will be the effect of treatment with vitamin E on airway reactivity to methacholine and specific allergen.
[Time Frame: After 16-18 weeks of treatment with vitamin E]
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Secondary ID(s)
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5 K23 HL080030-02
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IRB#051158
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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