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

Primary Purpose

Allergic Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Natural source d-α-tocopheryl acetate
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Allergic Asthma focused on measuring Asthma, Allergy, Atopy, Vitamin E, GSTP1, Oxidative stress

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dep. of Medicine, Div. of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Natural source d-α-tocopheryl acetate

Arm Description

1500 units daily for 16 weeks

Outcomes

Primary Outcome Measures

Effect of Natural-source d-α-tocopheryl Acetate on the Baseline and Allergen-induced Levels of F2-isoprostanes in the Bronchoalveolar Lavage Fluid (BAL)

Secondary Outcome Measures

Effect of Treatment With Vitamin E on Airway Reactivity to Methacholine
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL

Full Information

First Posted
December 22, 2007
Last Updated
March 2, 2018
Sponsor
Vanderbilt University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00581048
Brief Title
Study on the Role of Treatment With Vitamin E on Asthmatic Responses in Allergic Asthmatics
Official Title
Oxidant Stress and Allergic Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma
Keywords
Asthma, Allergy, Atopy, Vitamin E, GSTP1, Oxidative stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Natural source d-α-tocopheryl acetate
Arm Type
Experimental
Arm Description
1500 units daily for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Natural source d-α-tocopheryl acetate
Other Intervention Name(s)
Vitamin E
Intervention Description
1500 units daily for 16 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
Time Frame
baseline to after 16-18 weeks of treatment with vitamin E daily
Title
Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL
Time Frame
baseline to after 16-18 weeks of treatment with vitamin E daily

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryszard Dworski, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Medicine, Div. of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2650
Country
United States

12. IPD Sharing Statement

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