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

Completed · Not applicable

Conditions studied: Allergic Asthma

In brief

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.

Key facts

Study ID

NCT00581048

Run by

Vanderbilt University

People needed

33

Starts

2006-12-01

Expected to finish

2011-10-01

Last updated by the study team

2018-03-29

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Normal health status except for allergic asthma
• Physician diagnosis of mild allergic asthma
• Positive allergen skin tests to common aeroallergens

You may not qualify if…

• 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

Where it is running

• Dep. of Medicine, Div. of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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