Oxidant Stress and Allergic Asthma
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.
Status: Recruiting (N/A). Started on September 1st, 2006.
Enrollment: 40 subjects
Study Type: Interventional
Study Design:
- Intervention Model: Single Group Assignment
- Masking: Open Label
- Primary Purpose: Basic Science
Conditions:
Interventions:
- Dietary Supplement: Alpha-tocopherol
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 OTC 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
- Gender
Both
- Mininum Age
18 Years
- Maximum Age
50 Years
- Healthy Volunteers
No
Resources
Source: Vanderbilt University
Authority: United States: Food and Drug Administration
Locations
-
Dep. of Medicine, Div. of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University
Nashville
Tennessee
37232-2650
United States
Officials
Ryszard Dworski, MD (Principal Investigator, Vanderbilt University)
Sponsors
Vanderbilt University (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- November 1st, 2010
- First Received
- November 2nd, 2010
- Last Changed
- November 2nd, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.
The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.