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临床试验/NCT00142610
NCT00142610已完成1 期

Effect of Alpha Tocopherol and Ascorbate Supplementation on Airway Antioxidant Levels in Allergic Asthmatics

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2005年8月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
16
试验地点
2
主要终点
Sputum cell ascorbate and alpha-tocopherol levels; measured bi-weekly and at Week 12

研究概览

简要总结

This study will determine if airway antioxidant levels in allergic asthmatics are enhanced with a combination of vitamin E and vitamin C therapy.

详细描述

Eosinophils and neutrophils are inflammatory cells located in the airways and lungs. When they are activated, they generate oxidants, which irritates the mucosal cells in the airways. As a result, mucus develops in the lungs. Allergens can activate the inflammatory cells, thereby worsening the symptoms of asthma in allergic asthmatics. Vitamins E (alpha-tocopherol) and C (ascorbate) have been shown to decrease asthma exacerbation associated with exposure to ozone. Enhancing antioxidant and anti-inflammatory defenses in the airways and lungs is a promising approach for treating respiratory diseases aggravated by allergies. This study will determine if airway antioxidants in allergic asthmatics are enhanced with a combination of vitamin E and vitamin C therapy.

Participants in this double-blind study will be randomly assigned to receive either a combination of alpha-tocopherol and ascorbate or placebo. Treatments will be administered daily for 12 weeks. Baseline assessments will measure airway and circulating antioxidant levels, inflammatory cells, lung function, respiratory symptoms, and methacholine reactivity. Allergy skin tests will also be performed to determine the state of atopy, which is a hereditary predisposition toward developing certain hypersensitivity reactions. Following baseline assessments, lung assessments will be conducted weekly for 12 weeks, sputum and blood samples will be collected bi-weekly, and methacholine reactivity will be assessed at Weeks 6 and 12.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed allergy to at least one of the following allergen preparations: house dust mite f; house dust mite p; cockroach; tree mix; grass mix; weed mix; mold mix 1; mold mix 2; rat; mouse; guinea pig; rabbit; cat; or dog
  • Oxygen saturation greater than 94% at baseline
  • Systolic blood pressure between 150 and 90 mm Hg, diastolic blood pressure between 90 and 60 mm Hg
  • Physician-diagnosed asthma or history of episodic wheezing, chest tightness, or shortness of breath consistent with asthma
  • Airway reactivity as determined by either a provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used or 12% reversibility of baseline lung function with albuterol therapy for two of the three measures: FVC, FEV1, and FEF25-75%
  • Agree to discontinue use of vitamin supplements for the duration of the study
  • On a stable regimen of maintenance asthma therapy that has not changed within the month prior to participation

排除标准

  • Chronic medical condition that may make vitamin E and vitamin C treatment medically inadvisable (e.g., significant cardiovascular disease, diabetes requiring medication, chronic kidney disease, chronic thyroid disease, or coagulation defects)
  • History of kidney stones
  • Use of anticoagulants (e.g., warfarin, heparin, or clopindogrel)
  • Pregnant or breastfeeding
  • Use of inhaled steroids, cromolyn, or leukotriene inhibitors (Montelukast or Zafirkulast) for at least one month is not criteria for exclusion.

结局指标

主要结局

Sputum cell ascorbate and alpha-tocopherol levels; measured bi-weekly and at Week 12

时间窗: measurements have been made alalysis still occuring

次要结局

  • Methacholine reactivity; measured at Weeks 6 and 12(measure finished, analysis continues)
  • Lung function and symptom scores; measured weekly and at Week 12(measuremet finished, analysis continues)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David B. Peden, MD

Director Enviro Med Asthma & Lung Biology

University of North Carolina, Chapel Hill

研究点 (2)

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