Study on the Role of Treatment With Vitamin E on Asthmatic Responses in Allergic Asthmatics

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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 Over The Counter 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

Arm && Interventions

Group	Intervention	Description
Natural source d-α-tocopheryl acetate	Natural source d-α-tocopheryl acetate	1500 units daily for 16 weeks

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL	baseline to after 16-18 weeks of treatment with vitamin E daily
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL	baseline to after 16-18 weeks of treatment with vitamin E daily
Effect of Treatment With Vitamin E on Airway Reactivity to Methacholine	At baseline and After 16-18 weeks of treatment with vitamin E

Locations (1): Dep. of Medicine, Div. of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University
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Nashville, Tennessee, United States