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

NCT00581048 | Completed Results DMC

• 2 other identifiers: IRB#0511585K23HL080030-02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Asthma

Keywords

Asthma; Allergy; Atopy; Vitamin E; GSTP1; Oxidative stress

Outcome Measures

Primary Outcomes (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)

  At baseline to after 16-18 weeks of treatment with vitamin E daily

Secondary Outcomes (3)

• 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

Study Arms (1)

Natural source d-α-tocopheryl acetate

EXPERIMENTAL

1500 units daily for 16 weeks

Drug: Natural source d-α-tocopheryl acetate

Interventions

Natural source d-α-tocopheryl acetate DRUG

1500 units daily for 16 weeks

Also known as: Vitamin E

Natural source d-α-tocopheryl acetate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Normal health status except for allergic asthma
• Physician diagnosis of mild allergic asthma
• Positive allergen skin tests to common aeroallergens

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

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

Nashville, Tennessee, 37232-2650, United States

Location

MeSH Terms

Conditions

Asthma; Hypersensitivity

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Ryszard Dworski
• Organization: Vanderbilt University Medical Center

ryszard.dworski@Vanderbilt.Edu

615-322-3412

Study Officials

• Ryszard Dworski, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 22, 2007
• First Posted: December 27, 2007
• Study Start: December 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 29, 2018
• Results First Posted: February 6, 2018

Record last verified: 2018-03

Locations

US (1)