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临床试验/NCT03989271
NCT03989271招募中1 期

Impact of Quercetin on Inflammatory and Oxidative Stress Markers in COPD

Temple University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
29
试验地点
1
主要终点
Oxidative stress markers

研究概览

简要总结

This study determines whether quercetin supplementation reduces the inflammation and oxidative stress markers in patients with chronic obstructive pulmonary disease. It is small study with 8 subjects receive quercetin 2000 mg/day and 4 subjects receive placebo.

详细描述

Chronic obstructive pulmonary disease (COPD) is a progressive lung disorder and affects millions of people globally. Although the exact mechanisms of pathogenesis of this disease are not well-understood, the general consensus is that oxidative stress and inflammation induced by exposure to cigarette smoke or other environmental or occupational hazards are responsible for development of COPD. Therefore, therapies aimed at decreasing oxidative stress and inflammation constitutes an important component of treating COPD.

The current pharmacological therapies may provide temporary symptom relief, reduce acute exacerbations and hospitalizations, but are associated with side effects. Therefore complementary method of treatment with potentially fewer side effects and relatively well-tolerated provide promising alternative. One such compound is quercetin, which is plant polyphenol and is present in variety of foods that we consume. Quercetin has potent antioxidant and anti-inflammatory properties and reduces oxidative stress and inflammation in a preclinical model of COPD. Quercetin exerts it antioxidant properties not only by neutralizing free radical species, but also by enhancing the expression of antioxidant enzymes. Similarly, quercetin inhibits various protein and lipid kinases by competing for adenosine triphosphate (ATP) binding sites thus reducing the inflammatory pathways.

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)

盲法说明

Randomization codes will be generated by a study statistician at the begnining of the study and is provided to research pharmacist who will be dispensing the study drugs. The study drug bottles will be numbered with no information about the study drug. The randomization codes will not be revealed until all the data is collected and analyzed. Both placebo and quercetin will be similarly packaged and will have similar color, taste and texture.

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with COPD, 40 - 80 yrs of age
  • Post-bronchodilator forced expiratory volume (FEV)1/forced vital capacity (FVC) ratio 0.7, FEV1% predicted between 40 to 70
  • Both active and ex-smokers with at least 10 pack-years history of smoking
  • COPD patients taking H2 antagonists, loperamide or loratadine and willing to stop during the study period

排除标准

  • Known allergy/sensitivity to quercetin
  • Subjects with primary current diagnosis of asthma
  • Upper respiratory tract infection within two weeks of the screening visit
  • Acute bacterial infection requiring antibiotics within two weeks of screening
  • Emergency treatment or hospitalization within one month of screening for any reasons
  • Unwillingness to stop flavonoid supplementation
  • Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by Bioflavonoid Food and Supplement Screener
  • Daily warfarin or cyclosporine (Neoral, Sandimmune)
  • Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or loratadine and not willing to stop during study period
  • Lung cancer history or undergoing chemo- or radiation therapy
  • Inflammatory bowel disease
  • Subjects with no detectable levels of inflammatory CRP or SP-D in blood and/or IL-
  • 1β or 8-isoprostane in the exhaled breath condensate
  • Women of child-bearing age and unwilling to take pregnancy test
  • Child-bearing age, who are unwilling to use adequate contraception or abstain during the course of the study.
  • Pregnant or lactating mothers

研究组 & 干预措施

Quercetin

Active Comparator

Quercetin 2000 mg/day Quercetin is provided as orange flavored soft chews and each chew will have 250 mg of quercetin Quercetin will be administered orally twice daily, one half dose (4 chews) in the morning after breakfast and one half dose (4 chews) in the evening after dinner for six months.

干预措施: Quercetin (Drug)

Placebo

Placebo Comparator

Placebo is also provided as soft chews that is similar to quercetin in color, taste and texture and will contain all the stabilizers and the inactive ingredients that is present in the quercetin chews.

Placebo will be administered orally twice daily, one half dose (4 chews) in the morning after breakfast and one half dose (4 chews) in the evening after dinner for six months.

干预措施: Quercetin (Drug)

结局指标

主要结局

Oxidative stress markers

时间窗: six months

8-isoprostane

Inflammatory markers

时间窗: six months

Interleukin (IL)-1beta, IL-8, in bronchoalveolar lavage and C-reactive protein (CRP) and surfactant protein (SP)-D in serum

次要结局

  • Quercetin(six months)

研究者

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

Umadevi Sajjan

Associate Professor

Temple University

研究点 (1)

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