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

Allergic Asthma Clinical Trial

Official title:

Oxidant Stress and Allergic Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581048
• Other study ID #: IRB#051158
• Secondary ID: 5K23HL080030-02
• Status: Completed
• Phase: N/A
• First received: December 22, 2007
• Last updated: March 2, 2018
• Start date: December 2006
• Est. completion date: October 2011

Study information

• Verified date: March 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• Natural source d-a-tocopheryl acetate
1500 units daily for 16 weeks

Locations

Country	Name	City	State
United States	Dep. of Medicine, Div. of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Natural-source d-a-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	Effect of Treatment With Vitamin E on Airway Reactivity to Methacholine		At baseline and After 16-18 weeks of treatment with vitamin E
Secondary	Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL		baseline to after 16-18 weeks of treatment with vitamin E daily
Secondary	Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL		baseline to after 16-18 weeks of treatment with vitamin E daily