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Completed

NCT Number: NCT00581048

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

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.

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Key information

Conditions

Allergic Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Nashville, Tennessee, 37232-2650, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Natural source d-α-tocopheryl acetate

Drug

1500 units daily for 16 weeks

Other names: Vitamin E

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)

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Oxidant Stress and Allergic Asthma

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Dec 27, 2007
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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