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临床试验/NCT02885025
NCT02885025已完成2 期

Effects of Broccoli Sprout Extract on Allergic Rhinitis

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2016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
2 期
状态
已完成
入组人数
47
试验地点
1
主要终点
Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment

研究概览

简要总结

Allergic rhinitis is a common illness suffered among US Veterans. There are medications that help relieve allergy symptoms, including nasal steroid sprays and antihistamines. Some patients have increase symptoms with exposure to their trigger, such as a grasses when combined with pollution due to oxidative stress from pollution. In this study, patients with allergic rhinitis to grass will be given broccoli sprout extract that contains an antioxidant sulforaphane do see if there is beneficial effect in these patients.

详细描述

Allergic rhinitis is a common illness suffered among US Veterans. Despite the availability of medications, many patients fail to get adequate control of symptoms especially in high pollutant areas. Southern California air pollutants, like diesel exhaust particles may act as adjuvants to allergens leading to an exaggerated allergic response in certain individuals. These individuals may lack adequate Glutathione transferase activity; necessary to protect cells against pollutant induced oxidative stress. Sulforaphane has been shown to protect against oxidative stress. The investigators hypothesize consumption of foods containing high levels of sulforaphane are beneficial to US Veterans with GST deficiencies suffering from allergic rhinitis. In the investigators' preliminary data, the investigators discovered administration of broccoli sprout extract rich in sulforaphane leads to diminished nasal inflammatory reaction brought on by diesel exhaust particles though did not have sufficient patient numbers to prove an association with GST deficiency. The investigators propose a 3 week randomized clinical trial comparing broccoli sprout extract consumption with nasal corticosteroid administration after subjects with allergic rhinitis undergo a Timothy, Bermuda or Johnson grass nasal challenge. In Aims 1 and 2, the investigators will compare clinical (nasal symptom scores and peak nasal inspiratory flows) and laboratory (inflammatory cytokines, eosinophil cationic protein, tryptase) measurements between four groups: nasal corticosteroid, broccoli sprout extract, nasal corticosteroid plus broccoli sprout extract, and placebo. Aim 3 focuses on exploratory genetic analysis of the 3 glutathione S-transferase (GST) genes to determine if correlations exist between the inability to produce GST enzyme and the response to broccoli sprout extract. At the conclusion of this study, the investigators will gain further knowledge of which patients benefit from anti-oxidant nutritional supplementation in treating allergic rhinitis.

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
Triple (Participant, 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

  • Inclusion Criteria
  • Females and males 18 years or older.
  • History consistent with seasonal allergic rhinitis consistent with grass allergy (symptoms during summer months, June through August, for at least two consecutive seasons).
  • Not currently taking any medications for allergic rhinitis.
  • Provide written informed consent.
  • Willing and able to comply with all aspects of the protocol.

排除标准

  • The subject has any uncontrolled or serious disease, or any medical or surgical or condition that in the opinion of the investigator(s) could affect the subject's safety and/or interfere with the study assessments.
  • History of anaphylaxis to environmental allergens or an unknown trigger.
  • History of broccoli allergy
  • Recent upper respiratory infection (less than 4 weeks prior to study) or other active Infection.
  • Active smoker
  • Currently receiving allergy immunotherapy.
  • History of rhinitis exacerbation within the past 2 weeks.
  • Use of non-selective Beta-Blocker.
  • Inability to give written informed consent.
  • History or evidence of non-stable cognitive capacity within less than 1 year (i.e. Alzheimer's disease, dementia, bipolar disorder) that in the opinion of the investigator(s) could affect the subject's safety and/or interfere with the study assessments.
  • Perennial rhinitis
  • Uncontrolled asthma
  • Forced Expiratory Volume in 1 second <70% predicted at screening.

研究组 & 干预措施

BSE + Nasal Fluticasone

Active Comparator

subjects will be randomized into 1 of 4 arms:

  1. Broccoli Sprout Extract + Nasal Fluticasone
  2. Broccoli Sprout Extract + normal saline nasal spray
  3. Placebo Pill + Nasal Fluticasone
  4. Placebo Pill + normal saline nasal spray

干预措施: Broccoli Sprout Extract (Dietary Supplement)

BSE + Nasal Fluticasone

Active Comparator

subjects will be randomized into 1 of 4 arms:

  1. Broccoli Sprout Extract + Nasal Fluticasone
  2. Broccoli Sprout Extract + normal saline nasal spray
  3. Placebo Pill + Nasal Fluticasone
  4. Placebo Pill + normal saline nasal spray

干预措施: fluticasone nasal (Drug)

Broccoli Sprout Extract + normal saline nasal spray

Active Comparator

subjects will be randomized into 1 of 4 arms:

  1. Broccoli Sprout Extract + Nasal Fluticasone
  2. Broccoli Sprout Extract + normal saline nasal spray
  3. Placebo Pill + Nasal Fluticasone
  4. Placebo Pill + normal saline nasal spray

干预措施: Broccoli Sprout Extract (Dietary Supplement)

Broccoli Sprout Extract + normal saline nasal spray

Active Comparator

subjects will be randomized into 1 of 4 arms:

  1. Broccoli Sprout Extract + Nasal Fluticasone
  2. Broccoli Sprout Extract + normal saline nasal spray
  3. Placebo Pill + Nasal Fluticasone
  4. Placebo Pill + normal saline nasal spray

干预措施: normal saline nasal spray (Drug)

Placebo Pill + Nasal Fluticasone

Active Comparator

subjects will be randomized into 1 of 4 arms:

  1. Broccoli Sprout Extract + Nasal Fluticasone 2 Broccoli Sprout Extract + normal saline nasal spray 3. Placebo Pill + Nasal Fluticasone 4. Placebo Pill + normal saline nasal spray

干预措施: fluticasone nasal (Drug)

Placebo Pill + Nasal Fluticasone

Active Comparator

subjects will be randomized into 1 of 4 arms:

  1. Broccoli Sprout Extract + Nasal Fluticasone 2 Broccoli Sprout Extract + normal saline nasal spray 3. Placebo Pill + Nasal Fluticasone 4. Placebo Pill + normal saline nasal spray

干预措施: broccoli sprout extract placebo (Dietary Supplement)

Placebo Pill + normal saline nasal spray

Placebo Comparator

subjects will be randomized into 1 of 4 arms:

  1. Broccoli Sprout Extract + Nasal Fluticasone
  2. Broccoli Sprout Extract + normal saline nasal spray
  3. Placebo Pill + Nasal Fluticasone
  4. Placebo Pill + normal saline nasal spray

干预措施: broccoli sprout extract placebo (Dietary Supplement)

Placebo Pill + normal saline nasal spray

Placebo Comparator

subjects will be randomized into 1 of 4 arms:

  1. Broccoli Sprout Extract + Nasal Fluticasone
  2. Broccoli Sprout Extract + normal saline nasal spray
  3. Placebo Pill + Nasal Fluticasone
  4. Placebo Pill + normal saline nasal spray

干预措施: normal saline nasal spray (Drug)

结局指标

主要结局

Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment

时间窗: measures at various points following challenge at baseline and 21 days

The Immediate Total Nasal Symptom Score (TNSS): The TNSS has been used in prior interventional studies to evaluate different treatment modes for allergic rhinitis. The score will consist of subjects rating 4 symptoms (nasal congestion/postnasal drainage, nasal pruritus, rhinorrhea, or sneezing) on a scale of 0 to 3, where 0=no symptoms present, 1=mild symptoms that do not interfere with activity, 2=moderate symptoms that are slightly bothersome symptoms with slight interference with activity and/or nighttime sleep, or 3=severe symptoms with interference with activity and nighttime sleep. Thus minimal value would be 0 vs. maximal value would be a score of 12. A higher score correlates with higher rhinitis activity. Diminished scores following an intervention is consistent with an improvement in rhinitis symptoms.

Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment

时间窗: 21 days (from randomization to completion)

peak nasal inspiratory flow (PNIF) measures the peak flow during nasal inspiration with an approved device utilized in other studies. Measurements will be performed with TNSS (above).

次要结局

  • Interleukin 5 (IL5)(21 days (from randomization to completion))
  • Interleukin 4 (IL4)(21 days (from randomization to completion))
  • Interleukin 6 (IL6)(21 days (from randomization to completion))
  • Interleukin 8 (IL8)(21 days (from randomization to completion))
  • Interleukin 13 (IL13)(21 days (from randomization to completion))
  • Interleukin 1 Beta (IL1b)(21 days (from randomization to completion))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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