Effects of Broccoli Sprout Extract on Allergy Rhinitis

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02885025
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arms: 4
• Actual Duration (Months): 29.3
• Patients Per Site Per Month: 1.6

Study Details

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: broccoli 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
• Actual Enrollment: 47 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: Oct 1, 2016
• Actual Primary Completion Date: Mar 12, 2019
• Actual Study Completion Date: Mar 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BSE + Nasal Fluticasone subjects will be randomized into 1 of 4 arms: Broccoli Sprout Extract + Nasal Fluticasone Broccoli Sprout Extract + normal saline nasal spray Placebo Pill + Nasal Fluticasone 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: Broccoli Sprout Extract + normal saline nasal spray subjects will be randomized into 1 of 4 arms: Broccoli Sprout Extract + Nasal Fluticasone Broccoli Sprout Extract + normal saline nasal spray Placebo Pill + Nasal Fluticasone 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. 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	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.
Placebo Comparator: Placebo Pill + normal saline nasal spray subjects will be randomized into 1 of 4 arms: Broccoli Sprout Extract + Nasal Fluticasone Broccoli Sprout Extract + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray	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

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

1. Interleukin 5 (IL5) [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.

2. Interleukin 4 (IL4) [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.

3. Interleukin 6 (IL6) [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.

4. Interleukin 8 (IL8) [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.

5. Interleukin 13 (IL13) [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.

6. Interleukin 1 Beta (IL1b) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California	United States	90073

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 2, 2018
• Informed Consent Form - Nov 19, 2018

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02885025
• Other Study ID Numbers: CLNB-03-15F
• First Posted: Aug 31, 2016
• Last Update Posted: Jun 19, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Fluticasone

Study Results

Participant Flow

Recruitment Details	Patients were recruited from the VA Greater Los Angeles Healthcare System Allergy Immunology Clinic

Arm/Group Title	BSE + Nasal Fluticasone	BSE + Normal Saline Nasal Spray	Placebo Pill + Nasal Fluticasone	Placebo Pill + Normal Saline Nasal Spray
Arm/Group Description	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies. fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies. normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis. broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE. normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study
Period Title: Overall Study
STARTED	16	14	9	8
COMPLETED	16	12	9	8
NOT COMPLETED	0	2	0	0

Baseline Characteristics

Arm/Group Title	BSE + Nasal Fluticasone	BSE + Normal Saline Nasal Spray	Placebo Pill + Nasal Fluticasone	Placebo Pill + Normal Saline Nasal Spray	Total
Arm/Group Description	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies. fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies. normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis. broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE. normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study	Total of all reporting groups
Overall Participants	16	14	9	8	47
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	15 93.8%	12 85.7%	5 55.6%	7 87.5%	39 83%
>=65 years	1 6.3%	2 14.3%	4 44.4%	1 12.5%	8 17%
Sex: Female, Male (Count of Participants)
Female	4 25%	2 14.3%	3 33.3%	3 37.5%	12 25.5%
Male	12 75%	12 85.7%	6 66.7%	5 62.5%	35 74.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	3 18.8%	1 7.1%	1 11.1%	0 0%	5 10.6%
Native Hawaiian or Other Pacific Islander	2 12.5%	0 0%	0 0%	1 12.5%	3 6.4%
Black or African American	4 25%	5 35.7%	4 44.4%	4 50%	17 36.2%
White	7 43.8%	8 57.1%	3 33.3%	3 37.5%	21 44.7%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	1 11.1%	0 0%	1 2.1%
Region of Enrollment (Count of Participants)
United States	16 100%	14 100%	9 100%	8 100%	47 100%
PNIF (L/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [L/min]	105 (21.2)	120 (14.1)	172.5 (31.8)	170 (28.3)	155 (49.5)

Outcome Measures

1. Primary Outcome

Title	Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
Description	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.
Time Frame	measures at various points following challenge at baseline and 21 days

Outcome Measure Data

Analysis Population Description

intent to treat population (all participants assigned to 1 of the 4 groups above).

Arm/Group Title	BSE + Nasal Fluticasone	BSE + Normal Saline Nasal Spray	Placebo Pill + Nasal Fluticasone	Placebo Pill + Normal Saline Nasal Spray
Arm/Group Description	patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks	Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.	Patients received placebo tablet and nasal fluticasone for 3 weeks.	Patients received placebo tablet and normal saline nasal spray for 3 weeks
Measure Participants	16	12	9	8
Mean (Standard Deviation) [score on a scale]	-.5277 (0.1048)	-.5484 (.0014)	-.8359 (0.3903)	-.181 (.0846)

2. Primary Outcome

Title	Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
Description	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).
Time Frame	21 days (from randomization to completion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSE + Nasal Fluticasone	BSE + Normal Saline Nasal Spray	Placebo Pill + Nasal Fluticasone	Placebo Pill + Normal Saline Nasal Spray
Arm/Group Description	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies. fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies. normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis. broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE. normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study
Measure Participants	16	12	9	8
Mean (Standard Deviation) [L/min]	.3362 (.0026)	.1213 (.0607)	.0636 (.0485)	-.0538 (.0453)

3. Secondary Outcome

Title	Interleukin 5 (IL5)
Description	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.
Time Frame	21 days (from randomization to completion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSE + Nasal Fluticasone	BSE + Normal Saline Nasal Spray	Placebo Pill + Nasal Fluticasone	Placebo Pill + Normal Saline Nasal Spray
Arm/Group Description	patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks	Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.	Patients received placebo tablet and nasal fluticasone for 3 weeks.	Patients received placebo tablet and normal saline nasal spray for 3 weeks
Measure Participants	16	12	9	8
Mean (Standard Deviation) [log(pg/ml)]	-.5285 (.2236)	-.3213 (.2005)	-.1082 (.0083)	-.3755 (0.1866)

4. Secondary Outcome

Title	Interleukin 4 (IL4)
Description	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.
Time Frame	21 days (from randomization to completion)

Outcome Measure Data

Analysis Population Description

Patient diagnosed with grass induced allergic rhinitis were randomized into 1 of 4 groups.

Arm/Group Title	BSE + Nasal Fluticasone	BSE + Normal Saline Nasal Spray	Placebo Pill + Nasal Fluticasone	Placebo Pill + Normal Saline Nasal Spray
Arm/Group Description	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies. fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies. normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis. broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE. normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study
Measure Participants	16	12	9	8
Mean (Standard Deviation) [log(pg/ml)]	-.5655 (0.4738)	-.1076 (.0228)	-.3682 (.0294)	-.3695 (.233)

5. Secondary Outcome

Title	Interleukin 6 (IL6)
Description	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.
Time Frame	21 days (from randomization to completion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSE + Nasal Fluticasone	BSE + Normal Saline Nasal Spray	Placebo Pill + Nasal Fluticasone	Placebo Pill + Normal Saline Nasal Spray
Arm/Group Description	patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks	Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.	Patients received placebo tablet and nasal fluticasone for 3 weeks.	Patients received placebo tablet and normal saline nasal spray for 3 weeks
Measure Participants	16	12	9	8
Mean (Standard Deviation) [log(pg/ml)]	-1.0868 (.2903)	-.0519 (.2437)	-.2719 (1.6894)	.3567 (.2826)

6. Secondary Outcome

Title	Interleukin 8 (IL8)
Description	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.
Time Frame	21 days (from randomization to completion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BSE + Nasal Fluticasone	BSE + Normal Saline Nasal Spray	Placebo Pill + Nasal Fluticasone	Placebo Pill + Normal Saline Nasal Spray
Arm/Group Description	patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks	Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.	Patients received placebo tablet and nasal fluticasone for 3 weeks.	Patients received placebo tablet and normal saline nasal spray for 3 weeks
Measure Participants	16	12	9	8
Mean (Standard Deviation) [pg/ml log transformation]	-.7626 (.0168)	-.047 (.0033)	-.1013 (.2629)	.0472 (.1748)

7. Secondary Outcome

Title	Interleukin 13 (IL13)
Description	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.
Time Frame	21 days (from randomization to completion)

Outcome Measure Data

Analysis Population Description

Patient diagnosed with grass induced allergic rhinitis were randomized into 1 of 4 groups.

Arm/Group Title	BSE + Nasal Fluticasone	BSE + Normal Saline Nasal Spray	Placebo Pill + Nasal Fluticasone	Placebo Pill + Normal Saline Nasal Spray
Arm/Group Description	patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks	Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.	Patients received placebo tablet and nasal fluticasone for 3 weeks.	Patients received placebo tablet and normal saline nasal spray for 3 weeks
Measure Participants	16	12	9	8
Mean (Standard Deviation) [log(pg/ml)]	-1.0822 (.2568)	-.2985 (.0466)	.1577 (.1042)	-.0459 (.3745)

8. Secondary Outcome

Title	Interleukin 1 Beta (IL1b)
Description	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.
Time Frame	21 days (from randomization to completion)

Outcome Measure Data

Analysis Population Description

Patient diagnosed with grass induced allergic rhinitis were randomized into 1 of 4 groups

Arm/Group Title	BSE + Nasal Fluticasone	BSE + Normal Saline Nasal Spray	Placebo Pill + Nasal Fluticasone	Placebo Pill + Normal Saline Nasal Spray
Arm/Group Description	patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks	Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.	Patients received placebo tablet and nasal fluticasone for 3 weeks.	Patients received placebo tablet and normal saline nasal spray for 3 weeks
Measure Participants	16	12	9	8
Mean (Standard Deviation) [pg/ml with log transformation]	-.4058 (.2563)	.0183 (.037)	-.2382 (.3013)	.0713 (.1139)

Adverse Events

Time Frame	Adverse events were collected throughout the study. 1 year 6 months total.
Adverse Event Reporting Description	Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
Arm/Group Title	BSE + Nasal Fluticasone		BSE + Normal Saline Nasal Spray		Placebo Pill + Nasal Fluticasone		Placebo Pill + Normal Saline Nasal Spray
Arm/Group Description	subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies. no adverse events reported fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.		subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies. normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study		subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis. broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.		subjects will be randomized into 1 of 4 arms: BSE + Nasal Fluticasone BSE + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE. normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study
All Cause Mortality
	BSE + Nasal Fluticasone		BSE + Normal Saline Nasal Spray		Placebo Pill + Nasal Fluticasone		Placebo Pill + Normal Saline Nasal Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)		0/9 (0%)		0/8 (0%)
Serious Adverse Events
	BSE + Nasal Fluticasone		BSE + Normal Saline Nasal Spray		Placebo Pill + Nasal Fluticasone		Placebo Pill + Normal Saline Nasal Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)		0/9 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	BSE + Nasal Fluticasone		BSE + Normal Saline Nasal Spray		Placebo Pill + Nasal Fluticasone		Placebo Pill + Normal Saline Nasal Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/16 (18.8%)		4/14 (28.6%)		0/9 (0%)		2/8 (25%)
Gastrointestinal disorders
gi complaints	0/16 (0%)		0/14 (0%)		0/9 (0%)		1/8 (12.5%)	1
gi complaint	1/16 (6.3%)	1	0/14 (0%)	1	0/9 (0%)	1	0/8 (0%)	1
abdominal bloating	1/16 (6.3%)	1	0/14 (0%)	1	0/9 (0%)	1	0/8 (0%)	1
diarrhea	0/16 (0%)		1/14 (7.1%)	1	0/9 (0%)	1	0/8 (0%)	1
nausea	0/16 (0%)		1/14 (7.1%)	1	0/9 (0%)	1	0/8 (0%)	1
General disorders
nasal symptom	0/16 (0%)	0	1/14 (7.1%)	1	0/9 (0%)	0	0/8 (0%)	0
viral urti	1/16 (6.3%)	1	0/14 (0%)	1	0/9 (0%)	1	0/8 (0%)	1
nasal irritation	0/16 (0%)		1/14 (7.1%)	1	0/9 (0%)	1	0/8 (0%)	1
Musculoskeletal and connective tissue disorders
costochondritis	0/16 (0%)	0	0/14 (0%)	0	0/9 (0%)	0	1/8 (12.5%)	1

Limitations/Caveats

1. Difficult recruiting enough patients

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.