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

NCT ID: NCT00581048

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2011-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Natural source d-α-tocopheryl acetate

1500 units daily for 16 weeks

Group Type: EXPERIMENTAL

Natural source d-α-tocopheryl acetate

Intervention Type: DRUG

1500 units daily for 16 weeks

Interventions

Natural source d-α-tocopheryl acetate

1500 units daily for 16 weeks

Intervention Type: DRUG

Other Intervention Names

Vitamin E

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Ryszard T. Dworski

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryszard Dworski, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

5K23HL080030-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB#051158

Identifier Type: -

Identifier Source: org_study_id