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

Oxidant Stress and Allergic Asthma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00581048
Enrollment
33
Registered
2007-12-27
Start date
2006-12-31
Completion date
2011-10-31
Last updated
2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Asthma

Keywords

Asthma, Allergy, Atopy, Vitamin E, GSTP1, Oxidative stress

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.

Interventions

DRUGNatural source d-α-tocopheryl acetate

1500 units daily for 16 weeks

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Effect of Natural-source d-α-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

MeasureTime frame
Effect of Treatment With Vitamin E on Airway Reactivity to MethacholineAt baseline and After 16-18 weeks of treatment with vitamin E
Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BALbaseline to after 16-18 weeks of treatment with vitamin E daily
Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BALbaseline to after 16-18 weeks of treatment with vitamin E daily

Countries

United States

Participant flow

Participants by arm

ArmCount
Natural Source d-α-tocopheryl Acetate
1500 units daily for 16 weeks Natural source d-α-tocopheryl acetate: 1500 units daily for 16 weeks
33
Total33

Baseline characteristics

CharacteristicNatural Source d-α-tocopheryl Acetate
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
33 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
29 Participants
Region of Enrollment
United States
33 Participants
Sex: Female, Male
Female
22 Participants
Sex: Female, Male
Male
11 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 33
other
Total, other adverse events
0 / 33
serious
Total, serious adverse events
0 / 33

Outcome results

Primary

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

Population: Underlying data was lost. Go to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476459 Figure 1 for diagram of results

Secondary

Allergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL

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

ArmMeasureValue (MEDIAN)
Before Treatment, BaselineAllergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL4.05 UI/ml
After TreatmentAllergen-provoked Concentrations of Immunoglobulin E (IgE) in BAL3.65 UI/ml
Secondary

Allergen-provoked Concentrations of Th1 and Th2 Cytokines in BAL

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

ArmMeasureGroupValue (MEDIAN)
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-1B0.97 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-120.05 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-51.0 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-130.6 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-31.6 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALTNF-a2.76 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-621.5 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALINF-Y0.49 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-20.48 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALCXCL844.0 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-40.17 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALCCL53.0 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-100.53 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALCCL111.0 pg/mL
Before Treatment, BaselineAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-90 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALCCL112.70 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-1B1.21 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-20.69 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-31.4 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-40.045 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-50.8 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-617 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-90 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-100.7 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-120.165 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALIL-131.0 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALTNF-a3.02 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALINF-Y0.7 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALCXCL853.2 pg/mL
After TreatmentAllergen-provoked Concentrations of Th1 and Th2 Cytokines in BALCCL52.3 pg/mL
Secondary

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

Population: Underlying data was lost. Go to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3476459 Figure 2 for diagram of results

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026