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History of Changes for Study: NCT00882115
Broccoli Sprout Extract Effects and Allergic Inflammation in the Nose
Latest version (submitted September 18, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 14, 2009 None (earliest Version on record)
2 April 24, 2009 Study Status and Study Identification
3 May 7, 2009 Arms and Interventions, Study Description, Study Status, Conditions and Study Identification
4 May 13, 2009 Sponsor/Collaborators and Study Status
5 October 26, 2009 Recruitment Status, Contacts/Locations and Study Status
6 February 22, 2010 Study Design, Arms and Interventions and Study Status
7 December 6, 2010 Study Status and Sponsor/Collaborators
8 October 27, 2011 Recruitment Status, Study Status, Study Design, Contacts/Locations and Arms and Interventions
9 December 3, 2012 Recruitment Status, Study Status, Study Design, Arms and Interventions, Sponsor/Collaborators and Oversight
10 April 3, 2014 Study Status and References
11 June 12, 2014 Study Status
12 February 27, 2017 Sponsor/Collaborators, Arms and Interventions, Study Status, Study Identification, IPDSharing and Contacts/Locations
13 May 3, 2017 Outcome Measures, Study Status
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Results Submission Events
14 November 13, 2018 Study Status, Arms and Interventions, Results, Eligibility, Outcome Measures and Study Design
15 November 15, 2018 Outcome Measures and Study Status
16 September 18, 2019 Study Status
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Study NCT00882115
Submitted Date:  April 14, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: AADCRC-UCLA-01
Brief Title: Broccoli Sprout Extract Effects and Allergic Inflammation in the Nose
Official Title: Broccoli Sprout Extract Effects on the Inflammatory Response to Diesel Exhaust Particles in the Nose
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2009
Overall Status: Not yet recruiting
Study Start: April 2009
Primary Completion: April 2011 [Anticipated]
Study Completion:
First Submitted: April 14, 2009
First Submitted that
Met QC Criteria:
April 14, 2009
First Posted: April 16, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 14, 2009
Last Update Posted: April 16, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: Allergic airway disease is a term used to describe conditions such as allergic rhinitis and asthma. Among other causative agents, air pollutants and diesel exhaust in particular, have been shown to create and also worsen existing allergic airway disease. These inhaled pollution particles have oxidative properties that drive inflammation-related effects through specific metabolic-associated processes. These processes are not adequately suppressed by current therapeutics. The purpose of this study is to explore the effects of broccoli sprout extract (BSE) on the inflammatory process in the nose caused by Diesel exhaust particles, which are important elements in air pollution. BSE is a very potent inducer of Phase II enzymes (natural antioxidants).
Detailed Description:

Antioxidant enzymes are proteins produced by the body to protect cells against the harmful effects of chemicals, such as those found in air pollution. Particulate air pollution and Diesel exhaust in particular have been shown to cause and also exacerbate allergic airway disease. While there are ongoing efforts to improve air quality, there remains a need for alternative methods to address and prevent the adverse health effects of ambient air pollution, such as allergic rhinitis,, asthma, chronic obstructive pulmonary disease, and lung cancer. Currently, there are no therapeutic options which, directly target and address the effects of air pollutants in susceptible populations.

The purpose of this study is to examine the effect of BSE on airway inflammation caused by Diesel exhaust particles. This study will analyze whether BSE will increase the levels of the natural, helpful, antioxidant enzymes in the nose and as a result decrease the inflammation caused by nasal exposure to Diesel exhaust particles.

This study will last about six weeks and will recruit up to 100 participants. Only 30 participants will complete the entire study. Participants will attend up to ten clinical visits, which includes three screening visits. Some visits (2, 4, and 9) will last approximately 1 hour and require that the participants return to the clinic after 6 hours. The remaining visits (excluding Visit 1, which will also last about 1 hour) will take less than 30 minutes. Participants are restricted from consuming certain vegetables three days prior to, and during the course of the study.

During the screening phase, which will last from 4-5 days, and after giving informed consent participants will undergo a baseline evaluation that includes a medical history, a physical exam, blood drawing,allergy skin testing, nose washing, and a Diesel exhaust particle (DEP) challenge test. For the DEP test, a small amount of fluid containing DEP particles will be sprayed in the nose (this amount is equivalent to the DEP that one breathes in over 2 days in Los Angeles). Investigators will also screen for natural antioxidant-related genes antioxidant enzymes and other indicators of DEP sensitivity. Female participants of child bearing potential will have a urine pregnancy test.

Participants will be asked to drink BSE for four days in a row (visits 6, 7, 8, and 9). The dosage is less than 1 cup and requires that participants fast 2 hours before the study visits when BSE is ingested. This study requires that participants be allergic to cat. An allergy skin test will be performed to determine whether they have this kind of allergy.

Open or close this module Conditions
Conditions: Allergic Airway Disease
Keywords: DEP
BSE
Broccoli Sprout Extract
Allergies
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 1
Participants with and without DEP sensitivity
Drug: BSE
BSE will be ingested by drinking a liquid formula in a volume equaling less than 1 cup at study Visits 6,7,8, and 9
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Inhibition of mucosal inflammatory cells in nasal lavage
[ Time Frame: At 24 hours after DEP nasal challenge ]

Secondary Outcome Measures:
1. Selected DEP-related cytokines and chemokines, as measured by an ELISA test
[ Time Frame: At 6 and 24 hours after DEP nasal challenge ]

2. Phase II enzyme levels, as measured by RT-PCR
[ Time Frame: Post DEP nasal challenge ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Able and willing to provide informed consent
  • DEP responder as defined in protocol
  • Ability to refrain from consuming cruciferous vegetables 3 days prior to starting study and while on study. Cruciferous vegetables include: Broccoli, Kale, Chard, Kohrabi, Brussels Sprouts, Parsley, Watercress, Daikon, Cabbage, Rutabagas, Cauliflower, Bok Choy, Arrugula, Turnips, Radish, Mustard and Collard greens.
  • Allergy skin test positive to cat
  • Nonsmoker or ex-smoker of more than one year

Exclusion Criteria:

  • Smoking within past year or during study
  • Systemic corticosteroid or other immunosuppressive medication use in the previous 3 months or during study
  • Intranasal corticosteroid use in the previous month or during the study
  • Intranasal antihistamine or cromolyn use in the previous week or during study
  • Allergen immunotherapy during the previous 12 months or during study
  • Omalizumab use in the previous 12 months or during study
  • Systemic antihistamine or leukotriene modifying medication use in the previous week or during study
  • History of asthma or any current medical condition that in the opinion of the investigator may compromise the subject's ability to safely participate in the study
  • Baseline abnormality of hemoglobin, platelets, leukocytes, serum chemistries, liver function testing, or presence of proteinuria
  • A finding during physical examination that, in the opinion of the investigator may compromise the participant's ability to safely participate in the study
  • Pregnant or breast-feeding
Open or close this module Contacts/Locations
Central Contact Person: Kris Naowomondhol
Telephone: 310-825-5517
Study Officials: David Heber, MD, PhD
Study Chair
UCLA Department of Medicine
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Krewski D. Evaluating the effects of ambient air pollution on life expectancy. N Engl J Med. 2009 Jan 22;360(4):413-5. doi: 10.1056/NEJMe0809178. No abstract available. PubMed 19164194
Munday R, Mhawech-Fauceglia P, Munday CM, Paonessa JD, Tang L, Munday JS, Lister C, Wilson P, Fahey JW, Davis W, Zhang Y. Inhibition of urinary bladder carcinogenesis by broccoli sprouts. Cancer Res. 2008 Mar 1;68(5):1593-600. doi: 10.1158/0008-5472.CAN-07-5009. Epub 2008 Feb 29. PubMed 18310317
Parker JD, Akinbami LJ, Woodruff TJ. Air pollution and childhood respiratory allergies in the United States. Environ Health Perspect. 2009 Jan;117(1):140-7. doi: 10.1289/ehp.11497. Epub 2008 Sep 30. PubMed 19165401
Pope CA 3rd, Ezzati M, Dockery DW. Fine-particulate air pollution and life expectancy in the United States. N Engl J Med. 2009 Jan 22;360(4):376-86. doi: 10.1056/NEJMsa0805646. PubMed 19164188
Links:
Available IPD/Information:

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