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Effects of Broccoli Sprout Extract on Allergy Rhinitis

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ClinicalTrials.gov Identifier: NCT02885025
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rhinitis,Allergic Dietary Supplement: Broccoli Sprout Extract Drug: fluticasone nasal Dietary Supplement: brocooli sprout extract placebo Drug: normal saline nasal spray Phase 2

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Broccoli Sprout Extract on Allergic Rhinitis
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Fluticasone
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: BSE + Nasal Fluticasone

subjects will be randomized into 1 of 4 arms:

  1. BSE + Nasal Fluticasone
  2. BSE + normal saline nasal spray
  3. Placebo Pill + Nasal Fluticasone
  4. Placebo Pill + normal saline nasal spray
Dietary Supplement: Broccoli Sprout Extract
Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.
Drug: fluticasone nasal
fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.
Active Comparator: BSE + normal saline nasal spray

subjects will be randomized into 1 of 4 arms:

  1. BSE + Nasal Fluticasone
  2. BSE + normal saline nasal spray
  3. Placebo Pill + Nasal Fluticasone
  4. Placebo Pill + normal saline nasal spray
Dietary Supplement: Broccoli Sprout Extract
Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.
Drug: normal saline nasal spray
normal saline to replace nasal fluticasone in specific arms of the study
Active Comparator: Placebo Pill + Nasal Fluticasone

subjects will be randomized into 1 of 4 arms:

  1. BSE + Nasal Fluticasone
  2. BSE + normal saline nasal spray
  3. Placebo Pill + Nasal Fluticasone
  4. Placebo Pill + normal saline nasal spray
Drug: fluticasone nasal
fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.
Dietary Supplement: brocooli sprout extract placebo
a tablet similar to the actual broccoli sprout extract though without BSE.
Placebo Comparator: Placebo Pill + normal saline nasal spray

subjects will be randomized into 1 of 4 arms:

  1. BSE + Nasal Fluticasone
  2. BSE + normal saline nasal spray
  3. Placebo Pill + Nasal Fluticasone
  4. Placebo Pill + normal saline nasal spray
Dietary Supplement: brocooli sprout extract placebo
a tablet similar to the actual broccoli sprout extract though without BSE.
Drug: normal saline nasal spray
normal saline to replace nasal fluticasone in specific arms of the study


Outcome Measures

Primary Outcome Measures :
  1. total nasal symptom score (TNSS) change from baseline to 3 weeks of randomly assigned treatment [ Time Frame: Change in TNSS score after 3 weeks of treatment. Subjects will be randomly assigned to one of four treatment arms ]
    The total nasal symptom score (TNSS) has been determined from multiples studies to be highly reproducible as a marker in nasal challenges assessing treatment responses for allergic rhinitis.

  2. Peak Nasal Inspiratory Flow (PNIF) change from baseline to 3 weeks of randomly assigned treatment [ Time Frame: Change in PNIF score after 3 weeks of treatment. Subjects will be randomly assigned to one of four treatment arms ]
    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).


Secondary Outcome Measures :
  1. Biomarker level change from baseline to 3 weeks of randomly assigned treatment [ Time Frame: Change in biomarker levels after 3 weeks of treatment. Subjects will be randomly assigned to one of four treatment arms ]
    Biomarkers collected through sponges placed in both nasal passages during the challenge will include IL4, IL5, IL13, eosinophil cationic protein and tryptase.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion Criteria

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

Exclusion Criteria:

  1. 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.
  2. History of anaphylaxis to environmental allergens or an unknown trigger.
  3. History of broccoli allergy
  4. Recent upper respiratory infection (less than 4 weeks prior to study) or other active Infection.
  5. Active smoker
  6. Currently receiving allergy immunotherapy.
  7. History of rhinitis exacerbation within the past 2 weeks.
  8. Use of non-selective Beta-Blocker.
  9. Inability to give written informed consent.
  10. 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.
  11. Pregnancy
  12. Perennial rhinitis
  13. Uncontrolled asthma
  14. FEV1 (forced expiratory volume in 1 s) <70% predicted at screening.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885025


Contacts
Contact: Zhaoping Li, MD (310) 268-3528 zhaoping.li@va.gov
Contact: Joseph S Yusin, MD (310) 478-3711 ext 40230 Joseph.Yusin2@va.gov

Locations
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA Recruiting
West Los Angeles, California, United States, 90073
Contact: Zhaoping Li, MD    (310) 268-3528    zhaoping.li@va.gov   
Contact: Joseph S Yusin, MD    (310) 478-3711 ext 40230    Joseph.Yusin2@va.gov   
Principal Investigator: Joseph Stephen Yusin, MD         
Principal Investigator: Zhaoping Li, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Zhaoping Li, MD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Principal Investigator: Joseph Stephen Yusin, MD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02885025     History of Changes
Other Study ID Numbers: CLNB-03-15F
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
hypersensitivity
antioxidants

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Antioxidants
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents