Effects of Broccoli Sprout Extract on Allergy Rhinitis

NCT02885025 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CLNB-03-15F
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis,Allergic

Keywords

hypersensitivity; antioxidants

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (6)

• Interleukin 5 (IL5)

  21 days (from randomization to completion)

• Interleukin 4 (IL4)

  21 days (from randomization to completion)

• Interleukin 6 (IL6)

  21 days (from randomization to completion)

• Interleukin 8 (IL8)

  21 days (from randomization to completion)

• Interleukin 13 (IL13)

  21 days (from randomization to completion)

Study Arms (4)

BSE + 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

Dietary Supplement: Broccoli Sprout Extract; Drug: fluticasone nasal

Broccoli Sprout Extract + normal saline nasal spray

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

Dietary Supplement: Broccoli Sprout Extract; Drug: normal saline nasal spray

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

Drug: fluticasone nasal; Dietary Supplement: broccoli sprout extract placebo

Placebo Pill + normal saline nasal spray

PLACEBO 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

Dietary Supplement: broccoli sprout extract placebo; Drug: normal saline nasal spray

Interventions

Broccoli Sprout Extract DIETARY_SUPPLEMENT

Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.

BSE + Nasal Fluticasone; Broccoli Sprout Extract + normal saline nasal spray

fluticasone nasal DRUG

fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.

BSE + Nasal Fluticasone; Placebo Pill + Nasal Fluticasone

broccoli sprout extract placebo DIETARY_SUPPLEMENT

a tablet similar to the actual broccoli sprout extract though without BSE.

Placebo Pill + Nasal Fluticasone; Placebo Pill + normal saline nasal spray

normal saline nasal spray DRUG

normal saline to replace nasal fluticasone in specific arms of the study

Broccoli Sprout Extract + normal saline nasal spray; Placebo Pill + normal saline nasal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• History of anaphylaxis to environmental allergens or an unknown trigger.
• History of broccoli allergy
• Recent upper respiratory infection (less than 4 weeks prior to study) or other active Infection.
• Active smoker
• Currently receiving allergy immunotherapy.
• History of rhinitis exacerbation within the past 2 weeks.
• Use of non-selective Beta-Blocker.
• Inability to give written informed consent.
• 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.
• Pregnancy
• Perennial rhinitis
• Uncontrolled asthma
• Forced Expiratory Volume in 1 second \<70% predicted at screening.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Limitations and Caveats

1\. Difficult recruiting enough patients

Results Point of Contact

• Title: Joseph Yusin Chief division Allergy Immunology
• Organization: VA Greater Los Angeles Healthcare System

joseph.yusin2@va.gov

3104783711

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 31, 2016
• Study Start: October 1, 2016
• Primary Completion: March 12, 2019
• Study Completion: March 12, 2019
• Last Updated: June 19, 2020
• Results First Posted: June 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)