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

Vanderbilt University

Status

Completed

Conditions

Allergic Asthma

Treatments

Drug: Natural source d-α-tocopheryl acetate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00581048

5K23HL080030-02 (U.S. NIH Grant/Contract)

IRB#051158

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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 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