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

Oxidant Stress and Allergic Asthma

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.

Study Overview

• Status: Completed
• Conditions: Allergic Asthma
• Intervention / Treatment: Drug: Natural source d-α-tocopheryl acetate

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-2650
      • Dep. of Medicine, Div. of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Natural source d-α-tocopheryl acetate; 1500 units daily for 16 weeks	Drug: Natural source d-α-tocopheryl acetate; 1500 units daily for 16 weeks; Other Names: Vitamin E

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Ryszard Dworski, MD, Vanderbilt University

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: December 22, 2007
• First Submitted That Met QC Criteria: December 22, 2007
• First Posted (Estimate): December 27, 2007

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 2, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Oxidative stress; Asthma; Allergy; Vitamin E; Atopy; GSTP1
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol
• Other Study ID Numbers: IRB#051158; 5K23HL080030-02 (U.S. NIH Grant/Contract)