The Effects of Broccoli Sprout Extract on Obstructive Lung Disease
This study is currently recruiting participants.
Verified September 2012 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Robert Brown, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00994604
First received: October 13, 2009
Last updated: September 11, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and COPD.
| Condition | Intervention |
|---|---|
|
Asthma COPD |
Drug: broccoli sprout extract |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- The primary outcome is the change in bronchodilation and bronchoprotection after broccoli sprout extract [ Time Frame: end of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in biomarkers, Change in inflammatory mediators, Change in airway distensibility, Change in parenchyma [ Time Frame: end of study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: broccoli sprout extract |
Drug: broccoli sprout extract
consumption of broccoli sprout extract for 2 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994604
Contacts
| Contact: Curt Reynolds | 410-299-2429 |
Locations
| United States, Maryland | |
| Johns Hopkins Medical Institutions | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Curt Reynolds 410-299-2429 | |
| Principal Investigator: Robert H Brown, M.D., M.P.H. | |
Sponsors and Collaborators
Johns Hopkins University
More Information
No publications provided
| Responsible Party: | Robert Brown, Professor, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00994604 History of Changes |
| Other Study ID Numbers: | RB-001 |
| Study First Received: | October 13, 2009 |
| Last Updated: | September 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asthma Lung Diseases, Obstructive Bronchial Diseases Respiratory Tract Diseases Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013