Allergic AsthmaNCT00581048
Study on the Role of Treatment With Vitamin E on Asthmatic Responses in Allergic Asthmatics
A study testing Natural source d-α-tocopheryl acetate in people with Allergic Asthma, run by Vanderbilt University at 1 site in United States.
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 ( ). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Natural source d-α-tocopheryl acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Normal health status except for allergic asthma
- Physician diagnosis of mild allergic asthma
- Positive allergen skin tests to common aeroallergens
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dep. of Medicine, Div. of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University
Nashville, Tennessee, 37232-2650
About this study
Official title: 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.
- Conditions
- Allergic Asthma
- Being tested
- Natural source d-α-tocopheryl acetate
- Keywords
- Asthma, Allergy, Atopy, Vitamin E, GSTP1, Oxidative stress
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural source d-α-tocopheryl acetateDrug
Also called Vitamin E
1500 units daily for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Natural source d-α-tocopheryl acetate | Experimental | 1500 units daily for 16 weeks Receives: Drug: Natural source d-α-tocopheryl acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Natural-source d-α-tocopheryl Acetate on the Baseline and Allergen-induced Levels of F2-isoprostanes in the Bronchoalveolar Lavage Fluid (BAL)
Measured: 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
Measured: At baseline and After 16-18 weeks of treatment with vitamin E
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
Measured: baseline to after 16-18 weeks of treatment with vitamin E daily
Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL
Measured: baseline to after 16-18 weeks of treatment with vitamin E daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startDec 2006
- Primary completionApr 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ryszard T. Dworski, Vanderbilt University
- Investigators
- Ryszard Dworski, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581048
- Sponsor's protocol ID
- IRB#051158
- Other IDs
- 5K23HL080030-02
- Status last verified
- Mar 2018
- First submitted
- 22 Dec 2007
- Last updated
- 29 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidant Stress and Allergic Asthma
- ClinicalTrials.gov ID
- NCT00581048
- Acronym / sponsor ID
- IRB#051158
- Conditions
- Allergic Asthma
- Keywords
- Asthma, Allergy, Atopy, Vitamin E, GSTP1, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 6 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natural source d-α-tocopheryl acetate | Experimental | Drug: Natural source d-α-tocopheryl acetate1500 units daily for 16 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal health status except for allergic asthma
- Physician diagnosis of mild allergic asthma
- Positive allergen skin tests to common aeroallergens
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural source d-α-tocopheryl acetateAlso: Vitamin E1500 units daily for 16 weeks | Drug | Natural source d-α-tocopheryl acetate |
Primary outcome
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
3 secondary outcomes
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
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL
Time frame: baseline to after 16-18 weeks of treatment with vitamin E daily
Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL
Time frame: baseline to after 16-18 weeks of treatment with vitamin E daily
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Allergic Asthma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryszard Dworski, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural source d-α-tocopheryl acetate in people with Allergic Asthma, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.