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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BSE + Nasal Fluticasone | Active Comparator | subjects will be randomized into 1 of 4 arms:
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| Broccoli Sprout Extract + normal saline nasal spray | Active Comparator | subjects will be randomized into 1 of 4 arms:
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| 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 |
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| Placebo Pill + normal saline nasal spray | Placebo Comparator | subjects will be randomized into 1 of 4 arms:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Broccoli Sprout Extract | Dietary Supplement | Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment | 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. | measures at various points following challenge at baseline and 21 days |
| Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment | 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). | 21 days (from randomization to completion) |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin 5 (IL5) | 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. |
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Inclusion Criteria:
Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073 | United States |
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Patients were recruited from the VA Greater Los Angeles Healthcare System Allergy Immunology Clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | BSE + Nasal Fluticasone | subjects will be randomized into 1 of 4 arms:
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. |
| FG001 | BSE + Normal Saline Nasal Spray | subjects will be randomized into 1 of 4 arms:
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 |
| FG002 | Placebo Pill + Nasal Fluticasone | subjects will be randomized into 1 of 4 arms:
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. |
| FG003 | Placebo Pill + Normal Saline Nasal Spray | subjects will be randomized into 1 of 4 arms:
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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 47 subjects had a positive reaction to the up dose grass allergen challenge that began with 75 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | BSE + Nasal Fluticasone | subjects will be randomized into 1 of 4 arms:
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment | 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. | intent to treat population (all participants assigned to 1 of the 4 groups above). | Posted | Mean | Standard Deviation | score on a scale | measures at various points following challenge at baseline and 21 days |
|
Adverse events were collected throughout the study. 1 year 6 months total.
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BSE + Nasal Fluticasone | subjects will be randomized into 1 of 4 arms:
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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gi complaints | Gastrointestinal disorders | Non-systematic Assessment | Flatulence |
1. Difficult recruiting enough patients
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Yusin Chief division Allergy Immunology | VA Greater Los Angeles Healthcare System | 3104783711 | 40230 | joseph.yusin2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2018 | Feb 21, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 19, 2018 | Feb 21, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| fluticasone nasal | Drug | fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis. |
|
| broccoli sprout extract placebo | Dietary Supplement | a tablet similar to the actual broccoli sprout extract though without BSE. |
|
| normal saline nasal spray | Drug | normal saline to replace nasal fluticasone in specific arms of the study |
|
| 21 days (from randomization to completion) |
| Interleukin 4 (IL4) | 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. | 21 days (from randomization to completion) |
| Interleukin 6 (IL6) | 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. | 21 days (from randomization to completion) |
| Interleukin 8 (IL8) | 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. | 21 days (from randomization to completion) |
| Interleukin 13 (IL13) | 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. | 21 days (from randomization to completion) |
| Interleukin 1 Beta (IL1b) | 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. | 21 days (from randomization to completion) |
| BG001 | BSE + Normal Saline Nasal Spray | subjects will be randomized into 1 of 4 arms:
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 |
| BG002 | Placebo Pill + Nasal Fluticasone | subjects will be randomized into 1 of 4 arms:
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. |
| BG003 | Placebo Pill + Normal Saline Nasal Spray | subjects will be randomized into 1 of 4 arms:
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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| PNIF | Peak Nasal Inspiratory Flow: Range is 0 - 400 L/min. Note that increase in value is consistent with decreased nasal resistance consistent with an improvement. | Mean | Standard Deviation | L/min |
|
| Description |
|---|
| OG000 | BSE + Nasal Fluticasone | patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks |
| OG001 | BSE + Normal Saline Nasal Spray | Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks. |
| OG002 | Placebo Pill + Nasal Fluticasone | Patients received placebo tablet and nasal fluticasone for 3 weeks. |
| OG003 | Placebo Pill + Normal Saline Nasal Spray | Patients received placebo tablet and normal saline nasal spray for 3 weeks |
|
|
| Primary | Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment | 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). | Posted | Mean | Standard Deviation | L/min | 21 days (from randomization to completion) |
|
|
|
| Secondary | Interleukin 5 (IL5) | 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. | Posted | Mean | Standard Deviation | log(pg/ml) | 21 days (from randomization to completion) |
|
|
|
| Secondary | Interleukin 4 (IL4) | 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. | Patient diagnosed with grass induced allergic rhinitis were randomized into 1 of 4 groups. | Posted | Mean | Standard Deviation | log(pg/ml) | 21 days (from randomization to completion) |
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|
|
| Secondary | Interleukin 6 (IL6) | 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. | Posted | Mean | Standard Deviation | log(pg/ml) | 21 days (from randomization to completion) |
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|
|
| Secondary | Interleukin 8 (IL8) | 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. | Posted | Mean | Standard Deviation | pg/ml log transformation | 21 days (from randomization to completion) |
|
|
|
| Secondary | Interleukin 13 (IL13) | 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. | Patient diagnosed with grass induced allergic rhinitis were randomized into 1 of 4 groups. | Posted | Mean | Standard Deviation | log(pg/ml) | 21 days (from randomization to completion) |
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| Secondary | Interleukin 1 Beta (IL1b) | 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. | Patient diagnosed with grass induced allergic rhinitis were randomized into 1 of 4 groups | Posted | Mean | Standard Deviation | pg/ml with log transformation | 21 days (from randomization to completion) |
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| 0 |
| 16 |
| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | BSE + Normal Saline Nasal Spray | subjects will be randomized into 1 of 4 arms:
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 | 0 | 14 | 0 | 14 | 4 | 14 |
| EG002 | Placebo Pill + Nasal Fluticasone | subjects will be randomized into 1 of 4 arms:
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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Placebo Pill + Normal Saline Nasal Spray | subjects will be randomized into 1 of 4 arms:
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 | 0 | 8 | 0 | 8 | 2 | 8 |
| nasal symptom | General disorders | sneezing | Non-systematic Assessment | sneezing |
|
| costochondritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | patient went to ER during study for check pain that was reproducible and diagnosed with costochondritis |
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| gi complaint | Gastrointestinal disorders | Non-systematic Assessment | hemorrhoids |
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| viral urti | General disorders | Non-systematic Assessment | viral upper respiratory track infection (nasal congestion, sneezing and rhinorrhea) |
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| nasal irritation | General disorders | Non-systematic Assessment | nasal irritation |
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| abdominal bloating | Gastrointestinal disorders | Non-systematic Assessment | abdominal bloating |
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| diarrhea | Gastrointestinal disorders | Non-systematic Assessment | diarrhea |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment | nausea |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |