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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ryszard T. Dworski, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00581048
First received: December 22, 2007
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Allergic Asthma
 Drug: Natural source d-α-tocopheryl acetate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Oxidant Stress and Allergic Asthma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • The primary outcome will be the difference in allergen stimulated F2-Isoprostanes in BAL and EBC specimens. [ Time Frame: After 16-18 weeks of treatment with vitamin E daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome will be the effect of treatment with vitamin E on airway reactivity to methacholine and specific allergen. [ Time Frame: After 16-18 weeks of treatment with vitamin E ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: December 2006
Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Natural source d-α-tocopheryl acetate
    1500 units daily for 16 weeks
    Other Name: Carlson Laboratory, Arlington Heights, IL
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 OTC 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581048

Locations
United States, Tennessee
Dep. of Medicine, Div. of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University
Nashville, Tennessee, United States, 37232-2650
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Ryszard Dworski, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Ryszard T. Dworski, MD, PhD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00581048     History of Changes
Other Study ID Numbers: IRB#051158, 5 K23 HL080030-02
Study First Received: December 22, 2007
Last Updated: July 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Asthma
Allergy
Atopy
 Vitamin E
GSTP1
Oxidative stress

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamin E
 Alpha-Tocopherol
Tocopherols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013