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History of Changes for Study: NCT00994604
The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
Latest version (submitted December 5, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 13, 2009 None (earliest Version on record)
2 October 19, 2009 Arms and Interventions, Outcome Measures and Study Status
3 December 7, 2009 Recruitment Status, Study Status, Contacts/Locations and Eligibility
4 December 8, 2009 Eligibility and Study Status
5 March 28, 2012 Sponsor/Collaborators and Study Status
6 September 11, 2012 Arms and Interventions and Study Status
7 May 30, 2014 Recruitment Status, Contacts/Locations and Study Status
8 August 31, 2015 Recruitment Status and Study Status
9 December 5, 2016 Outcome Measures, Study Status, Study Design, Study Identification, Results, IPDSharing, Contacts/Locations, Arms and Interventions, Study Description and Oversight
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Study NCT00994604
Submitted Date:  October 13, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: RB-001
Brief Title: The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2009
Overall Status: Active, not recruiting
Study Start: October 2009
Primary Completion: June 2015 [Anticipated]
Study Completion:
First Submitted: October 13, 2009
First Submitted that
Met QC Criteria:
October 13, 2009
First Posted: October 14, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 13, 2009
Last Update Posted: October 14, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Johns Hopkins University
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: 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:
Open or close this module Conditions
Conditions: Asthma
COPD
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 150 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: broccoli sprout extract Drug: broccoli sprout extract
consumption of broccoli sprout extract for 2 weeks
No Intervention: normal medications Drug: broccoli sprout extract
consumption of broccoli sprout extract for 2 weeks
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The primary outcome is the change in bronchodilation and bronchoprotection after broccoli sprout extract
[ Time Frame: end of study ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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.
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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