Asthma, COPD
Conditions
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.
Interventions
consumption of broccoli sprout extract for 2 weeks
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Airway Size by Computed Tomography | baseline and after two weeks | Changes in size airways as measured by computed tomography |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Broccoli Sprout Extract broccoli sprout extract: consumption of broccoli sprout extract for 2 weeks | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Broccoli Sprout Extract |
|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 13 |
| Gender Female | 29 Participants |
| Gender Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
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
Time frame: baseline and two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Broccoli Sprout Extract - BP | The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract | 10.3 index | Standard Deviation 57.1 |
| Broccoli Sprout Extract - BD | The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract | 26.7 index | Standard Deviation 30.6 |
Changes in Airway Size by Computed Tomography
Changes in size airways as measured by computed tomography
Time frame: baseline and after two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Broccoli Sprout Extract - BP | Changes in Airway Size by Computed Tomography | 30.9 size in mm^2 | Standard Deviation 1.8 |
| Broccoli Sprout Extract - BD | Changes in Airway Size by Computed Tomography | 32 size in mm^2 | Standard Deviation 4.5 |