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The purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and COPD.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| broccoli sprout extract | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| broccoli sprout extract | Drug | consumption of broccoli sprout extract for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract | 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 | baseline and two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Airway Size by Computed Tomography | Changes in size airways as measured by computed tomography | baseline and after two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Brown, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Institutions | Baltimore | Maryland | 21205 | United States |
This was a pilot study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Broccoli Sprout Extract | pre- and post-consumption of broccoli sprout extract for 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Broccoli Sprout Extract | broccoli sprout extract: consumption of broccoli sprout extract for 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract | 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 | Posted | Mean | Standard Deviation | index | baseline and two weeks |
|
entire study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Broccoli Sprout Extract | pre- and post-consumption of broccoli sprout extract for 2 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Brown | Johns Hokpins Medical Institutions | 410-614-5451 | rbrown2@jhmi.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| years |
|
| Gender | Count of Participants | Participants |
|
| OG001 |
| Broccoli Sprout Extract - BD |
pre- and post-consumption of broccoli sprout extract for 2 weeks |
|
|
| Secondary | Changes in Airway Size by Computed Tomography | Changes in size airways as measured by computed tomography | Posted | Mean | Standard Deviation | size in mm^2 | baseline and after two weeks |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |