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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL080030-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Asthma is a common respiratory disease of unknown etiology which currently affects approximately 7.5 % of the adult population ( ). Asthma is an inflammatory disorder of the airways. Airway inflammation is evident not only in patients with fatal asthma but also in mild asthmatics ( ). Oxidant stress, defined as inadequately controlled generation of toxic reactive oxygen species (ROS) in the cells or tissues is a common feature of inflammation, and has also been documented in asthma ( , ). However, the current understanding of the relationship between the inflammation and the oxidant stress in asthmatic airways is poor. Does oxidant stress contribute to the expression of asthmatic phenotypes independently of inflammation? If so, could asthmatics benefit from supplementation of antioxidants? These questions have been nagging us since our laboratory provided credible evidence of oxidant injury in the airways of allergic asthmatics ( ). The purpose of our study is to more precisely determine 1/ the pathophysiologic role of oxidative stress, and 2/ usefulness of antioxidant therapy using vitamin E in allergic asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natural source d-α-tocopheryl acetate | Experimental | 1500 units daily for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural source d-α-tocopheryl acetate | Drug | 1500 units daily for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Natural-source d-α-tocopheryl Acetate on the Baseline and Allergen-induced Levels of F2-isoprostanes in the Bronchoalveolar Lavage Fluid (BAL) | At baseline to after 16-18 weeks of treatment with vitamin E daily |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Treatment With Vitamin E on Airway Reactivity to Methacholine | At baseline and After 16-18 weeks of treatment with vitamin E | |
| Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL | baseline to after 16-18 weeks of treatment with vitamin E daily |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryszard Dworski, MD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Medicine, Div. of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University | Nashville | Tennessee | 37232-2650 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Natural Source d-α-tocopheryl Acetate | 1500 units daily for 16 weeks Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Natural Source d-α-tocopheryl Acetate | 1500 units daily for 16 weeks Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of Natural-source d-α-tocopheryl Acetate on the Baseline and Allergen-induced Levels of F2-isoprostanes in the Bronchoalveolar Lavage Fluid (BAL) | Underlying data was lost. Go to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476459 Figure 1 for diagram of results | Posted | At baseline to after 16-18 weeks of treatment with vitamin E daily |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Natural Source d-α-tocopheryl Acetate | 1500 units daily for 16 weeks Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryszard Dworski | Vanderbilt University Medical Center | 615-322-3412 | ryszard.dworski@Vanderbilt.Edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL | baseline to after 16-18 weeks of treatment with vitamin E daily |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Effect of Treatment With Vitamin E on Airway Reactivity to Methacholine | Underlying data was lost. Go to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476459 Figure 2 for diagram of results | Posted | At baseline and After 16-18 weeks of treatment with vitamin E |
|
|
| Secondary | Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL | Posted | Median | Inter-Quartile Range | pg/mL | baseline to after 16-18 weeks of treatment with vitamin E daily |
|
|
|
| Secondary | Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL | Posted | Median | Inter-Quartile Range | UI/ml | baseline to after 16-18 weeks of treatment with vitamin E daily |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| IL-3 |
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| IL-4 |
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| IL-5 |
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| IL-6 |
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| IL-9 |
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| IL-10 |
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| IL-12 |
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| IL-13 |
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| TNF-a |
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| INF-Y |
|
| CXCL8 |
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| CCL5 |
|
| CCL11 |
|