Effects of Broccoli Sprout Extract on Allergy Rhinitis

• 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: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

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 (Clinical Trial)
• 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: October 1, 2016
• Actual Primary Completion Date: March 12, 2019
• Actual Study Completion Date: March 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 [ 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.
2. 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).

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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. Forced Expiratory Volume in 1 second <70% predicted at screening.

Contacts and Locations

Locations

United States, California

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)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] November 2, 2018

Informed Consent Form  [PDF] November 19, 2018

More Information

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

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; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; 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