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

Study Overview
=================
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.

Official Title
-----------------
Oxidant Stress and Allergic Asthma

Conditions
-----------------
Allergic Asthma

Intervention / Treatment
-----------------
* Drug: Natural source d-α-tocopheryl acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Natural source d-α-tocopheryl acetate<br>1500 units daily for 16 weeks | Drug: Natural source d-α-tocopheryl acetate<br>* 1500 units daily for 16 weeks<br>* Other names: Vitamin E;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL |  | baseline to after 16-18 weeks of treatment with vitamin E daily | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Allergy, Atopy, Vitamin E, GSTP1, Oxidative stress