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临床试验/NCT00262652
NCT00262652终止1 期

Sodium Pyruvate Bronchodilation in Asthmatics

Emphycorp2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年1月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
终止
发起方
入组人数
20
试验地点
2
主要终点
ANCOVA using multiple measures evaluating FEV1% predicted at 5, 15, 30, 60, 120 and 240 minutes between saline and Sodium Pyruvate,and at 5, 15 and 30 minutes between albuterol and Sodium Pyruvate with the visit baseline FEV1% predicted as covariate.

研究概览

简要总结

Sodium pyruvate in sodium chloride solution will be delivered by nebulization to the lungs. It is believed that this administration will produce bronchodilation in asthmatics as determined by improvement in FEV1. FEV1 is a measure of lung function, and will be determined after administration of sodium pyruvate. The study is a blinded, so subjects may receive either the sodium pyruvate or a sodium chloride placebo. The primary endpoint will be the improvement of FEV1 after 15 minutes in subjects receiving sodium pyruvate compared to the FEV1 of subjects receiving the sodium chloride placebo.

详细描述

Sodium Pyruvate, an intermediate metabolite, has been investigated as a therapeutic agent to reduce reactive oxygen species in the lung. Evaluation of FEV1 as a safety parameter and sequela of reactive oxygen species reduction identified inhaled Sodium Pyruvate as a potential bronchodilator.

A number of lung diseases are typically characterized by marked inflammation at the site of the lung injury. This inflammatory process leads to further destruction of surrounding healthy lung tissue, and a continuation and expansion of the sites of inflammation. This inflammatory process results in the production of reactive oxygen species, including superoxide anions and hydrogen peroxide, at the site of inflammation.

Nitric oxide is a known bronchodilator, as well as a vasodilator. It has been used successfully used to treat patients with various pulmonary disorders. 1 When endogenous nitric oxide is exposed to oxygen radicals, however, it is converted to the toxic oxidant nitrogen dioxide, and its bronchodilating effect is mitigated. Conversely, nitrogen dioxide is a known deep lung irritant. Its adverse consequences include the following: pulmonary inflammation; reduced levels of lung antioxidants 2; impairment of respiratory defense mechanisms leading to increased susceptibility to respiratory pathogens 3 and increased incidence and severity of respiratory infections; reduced lung function, and increased asthma and COPD symptoms.

Reactive oxygen species, especially superoxide anions, are known to compromise lung function by increasing bronchoconstriction. As a result of the increasing inflammation and the production of reactive oxygen species, and the decrease in nitric oxide that is believed to occur with the interstitial lung diseases, healthy tissue is damaged and lung function is compromised.

Based on our present understanding of the disease process involved with these lung diseases, it appears that an intervention in the inflammatory process that would result in a reduction in reactive oxygen species and a subsequent increase in nitric oxide could be an effective way to intervene in the disease process. This intervention would prevent the further spread of inflammation and lung damage caused by the production of reactive oxygen species, such as superoxide anions and hydrogen peroxide, and increase lung function by increasing bronchodilation.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A physician diagnosis of asthma
  • Age years old
  • Symptoms consistent with asthma for at least 6 months
  • Current asthma medications: Short-acting inhaled beta agonists as needed for control of asthma symptoms with or without a low to medium dose of an ICS, as defined in the table below and if on a ICS may also be on a long-acting beta agonist provided it is withheld for 24 hours prior to the testing days.
  • Inhaled Corticosteroid Dose less than or equal to:
  • Beclomethasone-HFA 480 µg/day Budesonide-DPI 1000 µg/day Flunisolide 2000 µg/day Fluticasone 500 µg/day Triamcinolone 2000 µg/day
  • FEV1 at screening 50-80% predicted (Hankinson6)
  • Reversibility with albuterol of 12% and 200 ml FEV1FEV1 at 30 minutes.

排除标准

  • 未提供

结局指标

主要结局

ANCOVA using multiple measures evaluating FEV1% predicted at 5, 15, 30, 60, 120 and 240 minutes between saline and Sodium Pyruvate,and at 5, 15 and 30 minutes between albuterol and Sodium Pyruvate with the visit baseline FEV1% predicted as covariate.

时间窗: Four Hour Testing

No other primary outcome variable

次要结局

未报告次要终点

研究者

发起方
Emphycorp
申办方类型
Industry

研究点 (2)

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