The Study of Soy Isoflavones in Asthma (SOYA)

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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 April 17, 2014