The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

• ClinicalTrials.gov Identifier: NCT00994604
• Recruitment Status: Completed
• First Posted: October 14, 2009
• Results First Posted: January 27, 2017
• Last Update Posted: January 27, 2017
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Robert Brown, Johns Hopkins University

Tracking Information

• First Submitted Date: October 13, 2009
• First Posted Date: October 14, 2009
• Results First Submitted Date: August 9, 2016
• Results First Posted Date: January 27, 2017
• Last Update Posted Date: January 27, 2017
• Study Start Date: October 2009
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 5, 2016)

The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract [ Time Frame: baseline and two weeks ]

Bronchodilator index = (1- ((1 - ((forced expiratory volume in 1 second after Methacholine A and after Deep Inspiration )÷( forced expiratory volume in 1 second baseline)))÷ (1 - ((forced expiratory volume in 1 second after Methacholine)÷( forced expiratory volume in 1 second baseline)))))x100 Bronchoprotection index = (1- ((1 - ((forced expiratory volume in 1 second after Deep Inspirations and after Methacholine B )÷( forced expiratory volume in 1 second baseline B)))÷(1 - ((forced expiratory volume in 1 second after Methacholine A)÷( forced expiratory volume in 1 second baseline A))))) x 100

• Original Primary Outcome Measures (submitted: October 13, 2009): The primary outcome is the change in bronchodilation and bronchoprotection after broccoli sprout extract [ Time Frame: end of study ]

Current Secondary Outcome Measures (submitted: December 5, 2016)

Changes in Airway Size by Computed Tomography [ Time Frame: baseline and after two weeks ]

Changes in size airways as measured by computed tomography

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
• Official Title: The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
• Brief Summary: The purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and COPD.

Detailed Description

Asthma afflicts 23 million people, results in nearly 13 million ambulatory physician encounters, and 440,000 hospitalizations annually. The economic burden for 2010 is estimated to run $20.7 billion.

Although steroids are the mainstay of treatment, they do not "cure" the disease. While inflammation may be the inciting factor, other mechanisms must play a crucial role in this process. Elevated oxidative stress could cause the kind of chronic inflammation associated with asthma, and could provide an explanation for recurrent asthma attacks. Cigarette smoke, both primary and secondary exposure, worsens the oxidative stress balance in the airways. Thus, the continuing focus on simply treating the inflammation is a barrier to progress. It is critical to examine other factors, such as abnormal oxidative stress through specific pathways that may affect airway inflammation and asthma attacks.

One compound, that repairs oxidative stress pathways, is sulforaphane, a food compound found in vegetables, including broccoli sprouts. Preliminary data demonstrate that broccoli sprout extract (BSE), rich in sulforaphane, improves airflow measures in asthmatics.

We plan to examine whether the airflow abnormalities in asthma, and the exacerbation from cigarette smoke, can be prevented by the administration of BSE, and determine the primary inflammatory and oxidative stress signaling pathways involved in the protection provided by BSE.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

• Asthma
• COPD

Intervention

Drug: broccoli sprout extract

consumption of broccoli sprout extract for 2 weeks

Study Arms

Experimental: broccoli sprout extract

This a before and after treatment study. The subjects will consumer broccoli sprout extract (BSE) for two weeks (14d). Lung function and Chest CT will be performed before and after BSE consumption.

Intervention: Drug: broccoli sprout extract

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 5, 2016): 51
• Original Estimated Enrollment (submitted: October 13, 2009): 150
• Actual Study Completion Date: August 2015
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• asthma
• COPD

Exclusion Criteria:

• currently on chronic oral steroid medications
• current respiratory symptoms
• pregnant
• FEV1 less than 40% predicted at baseline
• extreme degrees of bronchial hyperreactivity
• recent respiratory infection (<3 weeks)
• unstable symptoms in the prior month
• a history of intubation for respiratory symptoms within the past year
• any history of cardiac disease.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00994604
• Other Study ID Numbers: RB-001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: This was a pilot study.

• Current Responsible Party: Robert Brown, Johns Hopkins University
• Original Responsible Party: Robert Brown, Johns Hopkins Medicine
• Current Study Sponsor: Johns Hopkins University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robert Brown, MD; Johns Hopkins University

• PRS Account: Johns Hopkins University
• Verification Date: December 2016