Asthma Clinical Trial
Official title:
Dietary Interventions in Asthma Treatment: Sprouts Study
Verified date | May 2019 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Sulforaphane (SFN) is a naturally occurring isothiocyanate that is a potent inducer of Phase
II enzymes which play a critical role in preventing oxidative stress (via activation of
Nrf2). Broccoli sprouts (BS) contain the richest source of SFN.
The main objectives of this study are to test the effect of broccoli sprouts (BS) on
biomarkers of oxidative stress (OS), inflammation, basophil activation, and clinical outcomes
in mouse allergen-induced asthma by (1) determining if BS improves lung function and airways
symptom responses in mouse-sensitized adults with asthma undergoing environmental mouse
allergen challenge (EMAC), (2) examining the effect of BS on OS, inflammation, and basophil
activation, and (3) examining the effect of BS on changes in OS, inflammation, and basophil
activation after EMAC.
Status | Terminated |
Enrollment | 1 |
Est. completion date | February 6, 2012 |
Est. primary completion date | February 6, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - Age 18-49 years - Physician-diagnosed asthma - No other major pulmonary disease such as cystic fibrosis or chronic obstructive pulmonary disease (COPD) - Mouse sensitization, defined by a positive skin prick test to mouse epithelial extract or positive mouse-specific immunoglobulin E (IgE) - Non-smoker Exclusion Criteria: - Severe or unstable asthma defined as requiring hospitalization in the previous year or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids - Baseline FEV1 and FEV1/forced vital capacity (FVC) < 70% predicted - Positive skin prick test (SPT) to a pet currently living in the participant's home - Other significant medical issues such as heart disease or poorly controlled hypertension, or hypothyroidism - Pregnancy or nursing/breastfeeding mothers - On beta-blocker therapy - Taking anti-oxidant supplements - Unable to stop antihistamines prior to skin testing - Unable to stop medications that may interfere with allergen challenge responses prior to challenges. - The participant has food allergy to BS or AS. - Omalizumab use within the last 12 months. - Oral corticosteroid use within the last 2 weeks. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Massachusetts General Hospital, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Forced Expiratory Volume at One Second (FEV1) | The percentage change in FEV1 from the pre-challenge FEV1 value over the 1 hour mouse chamber exposure. | 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|