The Study of Soy Isoflavones in Asthma (SOYA)
This study is ongoing, but not recruiting participants.
Sponsor:
American Lung Association Asthma Clinical Research Centers
Collaborators:
Information provided by (Responsible Party):
American Lung Association Asthma Clinical Research Centers
ClinicalTrials.gov Identifier:
NCT01052116
First received: December 4, 2009
Last updated: June 26, 2012
Last verified: June 2012
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Purpose
The trial is designed to study the effects of soy supplements on asthma control.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Soy isoflavone supplement Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | The Study of Soy Isoflavones in Asthma |
Resource links provided by NLM:
Further study details as provided by American Lung Association Asthma Clinical Research Centers:
Primary Outcome Measures:
- FEV1 assessed by forced expiratory spirometry before and after two inhalations of albuterol [ Time Frame: -4 weeks, 0 weeks, and every 4 weeks for 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Exhaled Nitric Oxide [ Time Frame: Every 4 weeks for 6 months ] [ Designated as safety issue: No ]
- Asthma control as measured with the Juniper Asthma Control Questionnaire (ACQ) [ Time Frame: -4 weeks, 0 weeks, and every 4 weeks for 6 months ] [ Designated as safety issue: No ]
- Asthma diary [ Time Frame: Daily for 6 months ] [ Designated as safety issue: No ]
- Episodes of poor asthma control (EPAC) [ Time Frame: Every 4 weeks for 6 months ] [ Designated as safety issue: No ]
- Increased use of bronchodilator rescue medicine over baseline [ Time Frame: Every 4 weeks for 6 months ] [ Designated as safety issue: No ]
- Asthma Symptom Utility Index (ASUI) [ Time Frame: Every 4 weeks for 6 months ] [ Designated as safety issue: No ]
- Asthma specific and generic health-related quality of life [ Time Frame: Every 4 weeks for 6 months ] [ Designated as safety issue: No ]
- Airway reactivity as measured with methacholine challenge testing [ Time Frame: -4 weeks if necessary ] [ Designated as safety issue: No ]
- Side effects and toxicity [ Time Frame: Every 4 weeks for 6 months ] [ Designated as safety issue: Yes ]
- Genistein levels [ Time Frame: 0 weeks, 4 weeks, 24 weeks ] [ Designated as safety issue: No ]
- Peripheral blood eosinophil counts [ Time Frame: 0 weeks, 4 weeks, 24 weeks ] [ Designated as safety issue: No ]
- Interleukin-6 (IL-6) and C-Reactive Protein (CRP) [ Time Frame: 0 weeks, 4 weeks, 24 weeks ] [ Designated as safety issue: No ]
- Urinary LTE4 levels [ Time Frame: 0 weeks, 4 weeks, 24 weeks ] [ Designated as safety issue: No ]
- Genotyping to determine genetic determinants of soy isoflavone effects (optional for participation) [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 380 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Soy Isoflavone
Oral isoflavone supplement (100 mg/day)
|
Drug: Soy isoflavone supplement
Oral soy isoflavone supplement (100 mg/day)
Other Name: Soy supplement
|
|
Placebo Comparator: Placebo
Matching placebo
|
Drug: Placebo
Placebo
|
Detailed Description:
Asthma is a common disease that has a major impact on morbidity and health care costs. Although the prevalence and severity of asthma have increased over the last several decades, the specific causes remain unknown. One possible mechanism is a change in diet. Yet, epidemiological and interventional studies designed to identify a key nutrient or antioxidant vitamin that may be responsible for the increase in disease severity have produced inconsistent results. A recent pilot study showed a soy isoflavone supplement reduces exhaled nitric oxide (FeNO) and ex vivo LTC4 synthesis in patients with inadequately controlled asthma. This clinical trial is designed to test the novel hypothesis that dietary supplementation with soy isoflavones is an effective treatment in patients with poorly controlled asthma. The study will include 380 patients with low dietary soy intake, 12 years of age or older, who are taking either inhaled corticosteroids or leukotriene modifiers and have inadequately controlled asthma. Participants will be randomly assigned to treatment with either a soy isoflavone supplement (containing genistein, daidzein and glycitein; 100 mg daily of the glycoside forms) or placebo for six months. The results of this trial will increase understanding of the role of diet in asthma; could identify a novel, safe and relatively inexpensive treatment for patients with asthma; and potentially will have a substantial impact on public health in the United States.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 12 or older
Physician diagnosed asthma
- FEV1 equal or greater than 50% predicted pre-bronchodilator
- At least 12% increase in FEV1 15-3 minutes after inhaling 2-4 puffs of albuterol or positive methacholine challenge (20% fall in FEV1 at less than 8 mg/mL). Either of these can be available from the previous 2 years
- Currently prescribed daily controller asthma medication
Poor asthma control (at least one of the following)
- A score of 1.5 or greater on the Juniper Asthma Control Questionnaire
- Use of beta-agonist for asthma symptoms two or more times per week
- Nocturnal awakening with asthma symptoms more than once per week
- Two or more episodes of asthma symptoms in the past 12 months with each requiring at least one of the following: emergency department visit, unscheduled physician visit, prednisone course, hospitalization
Smoking status
- Non-smoker for 6 months or longer
- Less than 10 pack-years smoking history
Exclusion Criteria:
Pulmonary function
- FEV1 less than 50% predicted pre-bronchodilator
Other major chronic illnesses
- Conditions which in the judgment of the study physician would interfere with participation in the study, e.g., non-skin cancer, endocrine disease, coronary artery disease, severe hypertension, immunodeficiency states
- History of thyroid disease, breast cancer, ovarian, or endometrial cancer
- History of physician diagnosis of chronic bronchitis, emphysema, or COPD
Medication use
- Current consumption of soy isoflavone supplements
- Oral corticosteroid use within the past 6 weeks
- Use of tamoxifen
- Use of an investigational treatment in the previous 30 days
"Drug" allergy
- Known adverse reaction to genistein, other phytoestrogens, or soy products
Females of childbearing potential
- Pregnant or lactating. Participants must agree to use effective contraception during the trial.
Non-adherence
- Inability or unwillingness to provide consent or, in the case of children, inability or unwillingness of the child to provide assent
- Inability to swallow study medication
- Inability to perform baseline measurements
- Completion of less than 10 of the last 14 days diary entries during screening period
- Inability to be contacted by telephone
- Intention to move out of the area within 6 months
Other
- Recent asthma exacerbation (within 6 weeks)
- Recent upper respiratory infection (within 2 weeks)
- Body weight less than 77 pounds (35 kg)
- Intake of soy or soy-enriched foods 1 or more times a week
- Change in diet over the past month or expected change in diet during the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052116
Locations
| United States, Arizona | |
| University of Arizona | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| University of California, San Diego | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| National Jewish Health | |
| Denver, Colorado, United States, 80206 | |
| United States, Florida | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| University of South Florida College of Medicine | |
| Tampa, Florida, United States, 33613 | |
| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Louisiana State University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Missouri | |
| University of Missouri, Kansas City School of Medicine | |
| Kansas City, Missouri, United States, 64108 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| North Shore - Long Island Jewish Health System | |
| New Hyde Park, New York, United States, 11040 | |
| New York University School of Medicine | |
| New York, New York, United States, 10016 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Davis Heart and Lung Research Institute | |
| Columbus, Ohio, United States, 43210 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Vermont | |
| Vermont Lung Center at the University of Vermont | |
| Burlington, Vermont, United States, 05405 | |
Sponsors and Collaborators
American Lung Association Asthma Clinical Research Centers
Investigators
| Principal Investigator: | Lewis J Smith, MD | Northwestern University |
More Information
Additional Information:
No publications provided
| Responsible Party: | American Lung Association Asthma Clinical Research Centers |
| ClinicalTrials.gov Identifier: | NCT01052116 History of Changes |
| Other Study ID Numbers: | ALAACRC-10, RO1HL087987-01A2, R01 HL0088367-01A2 |
| Study First Received: | December 4, 2009 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by American Lung Association Asthma Clinical Research Centers:
|
Asthma Soy Supplement ACRC SOYA |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013