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Effects of Broccoli Sprout Extract on Allergy Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02885025
Recruitment Status : Completed
First Posted : August 31, 2016
Results First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE August 23, 2016
First Posted Date  ICMJE August 31, 2016
Results First Submitted Date  ICMJE April 7, 2020
Results First Posted Date  ICMJE June 19, 2020
Last Update Posted Date June 19, 2020
Actual Study Start Date  ICMJE October 1, 2016
Actual Primary Completion Date March 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
  • Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment [ Time Frame: 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 [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
  • 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.
  • 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
  • Interleukin 5 (IL5) [ Time Frame: 21 days (from randomization to completion) ]
    Interleukin 5 (IL5) is considered a T2 cytokine that increases with exacerbations of atopic disease, including allergic rhinitis. Cytokine measurements are in pg/ml. Values are recorded with log transformation. Note that measurements are on a continuous score. Lower values are consistent with less T2 inflammation which is consistent with diminished or lower atopic/allergic response.
  • Interleukin 4 (IL4) [ Time Frame: 21 days (from randomization to completion) ]
    Interleukin 4 (IL4) is considered a T2 cytokine that increases with exacerbations of atopic disease, including allergic rhinitis. Cytokine measurements are in pg/ml. Values are recorded with log transformation. Note that measurements are on a continuous score. Lower values are consistent with less T2 inflammation which is consistent with diminished or lower atopic/allergic response.
  • Interleukin 6 (IL6) [ Time Frame: 21 days (from randomization to completion) ]
    Interleukin 6 is a cytokine present during inflammatory process. This is recorded in pg/ml. Below is the log transformation of the pg/ml unit. Note that measurements are on a continuous score. Lower values are consistent with less inflammation which could occur with an inflammatory response.
  • Interleukin 8 (IL8) [ Time Frame: 21 days (from randomization to completion) ]
    Interleukin 8 s a cytokine that will increase with inflammation. Below is the log transformation of the pg/ml unit. Note that measurements are on a continuous score. Lower values are consistent with less inflammation which could occur with an inflammatory response.
  • Interleukin 13 (IL13) [ Time Frame: 21 days (from randomization to completion) ]
    Interleukin 13 (IL13) is considered a T2 cytokine that increases with exacerbations of atopic disease, including allergic rhinitis. Cytokine measurements are in pg/ml. Values are recorded with log transformation. Note that measurements are on a continuous score. Lower values are consistent with less T2 inflammation which is consistent with diminished or lower atopic/allergic response.
  • Interleukin 1 Beta (IL1b) [ Time Frame: 21 days (from randomization to completion) ]
    IL1b is a cytokine that will increase with inflammation. Below is the log transformation of the pg/ml unit. Note that measurements are on a continuous score. Lower values are consistent with less inflammation which could occur with an inflammatory response.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Broccoli Sprout Extract on Allergy Rhinitis
Official Title  ICMJE Effects of Broccoli Sprout Extract on Allergic Rhinitis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rhinitis,Allergic
Intervention  ICMJE
  • 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.
  • Dietary Supplement: broccoli 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
Study Arms  ICMJE
  • Active Comparator: BSE + Nasal Fluticasone

    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
    Interventions:
    • Dietary Supplement: Broccoli Sprout Extract
    • Drug: fluticasone nasal
  • Active Comparator: Broccoli Sprout Extract + normal saline nasal spray

    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
    Interventions:
    • Dietary Supplement: Broccoli Sprout Extract
    • Drug: normal saline nasal spray
  • Active Comparator: Placebo Pill + Nasal Fluticasone

    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

    Interventions:
    • Drug: fluticasone nasal
    • Dietary Supplement: broccoli sprout extract placebo
  • Placebo Comparator: Placebo Pill + normal saline nasal spray

    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
    Interventions:
    • Dietary Supplement: broccoli sprout extract placebo
    • Drug: normal saline nasal spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2020)
47
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2016)
475
Actual Study Completion Date  ICMJE March 12, 2019
Actual Primary Completion Date March 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Forced Expiratory Volume in 1 second <70% predicted at screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02885025
Other Study ID Numbers  ICMJE CLNB-03-15F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account VA Office of Research and Development
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP