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

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ClinicalTrials.gov Identifier: NCT00581048
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : February 6, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ryszard T. Dworski, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Allergic Asthma Drug: Natural source d-α-tocopheryl acetate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Oxidant Stress and Allergic Asthma
Study Start Date : December 2006
Actual Primary Completion Date : April 2011
Actual Study Completion Date : October 2011


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 Name: Vitamin E




Primary Outcome Measures :
  1. Effect of Natural-source d-α-tocopheryl Acetate on the Baseline and Allergen-induced Levels of F2-isoprostanes in the Bronchoalveolar Lavage Fluid (BAL) [ Time Frame: At baseline to after 16-18 weeks of treatment with vitamin E daily ]

Secondary Outcome Measures :
  1. Effect of Treatment With Vitamin E on Airway Reactivity to Methacholine [ Time Frame: At baseline and After 16-18 weeks of treatment with vitamin E ]
  2. Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL [ Time Frame: baseline to after 16-18 weeks of treatment with vitamin E daily ]
  3. Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL [ Time Frame: baseline to after 16-18 weeks of treatment with vitamin E daily ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Ryszard Dworski, MD Vanderbilt University

Responsible Party: Ryszard T. Dworski, MD, PhD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00581048     History of Changes
Other Study ID Numbers: IRB#051158
5K23HL080030-02 ( U.S. NIH Grant/Contract )
First Posted: December 27, 2007    Key Record Dates
Results First Posted: February 6, 2018
Last Update Posted: March 29, 2018
Last Verified: March 2018

Keywords provided by Ryszard T. Dworski, 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
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents