The Study of Soy Isoflavones in Asthma (SOYA)

The trial is designed to study the effects of soy supplements on asthma control.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Soy isoflavone supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 386
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • California
    • San Diego, California, United States, 92103
      • University of California, San Diego
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Nemours Children's Clinic
    • Miami, Florida, United States, 33136
      • University of Miami School of Medicine
    • Tampa, Florida, United States, 33613
      • University of South Florida College of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Northwestern Memorial Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Sciences Center
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • University of Missouri, Kansas City School of Medicine
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • New Hyde Park, New York, United States, 11040
      • North Shore - Long Island Jewish Health System
    • New York, New York, United States, 10016
      • New York University School of Medicine
    • Valhalla, New York, United States, 10595
      • New York Medical College
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Davis Heart and Lung Research Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Vermont
    • Burlington, Vermont, United States, 05405
      • Vermont Lung Center at The University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; Placebo
Active Comparator: Soy Isoflavone; Oral isoflavone supplement (100 mg/day)	Drug: Soy isoflavone supplement; Oral soy isoflavone supplement (100 mg/day); Other Names: Soy supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Change From Baseline to 24 Weeks for FEV1	24 weeks

Collaborators and Investigators

• Sponsor: American Lung Association Asthma Clinical Research Centers
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Lewis J Smith, MD, Northwestern University

Publications and helpful links

General Publications

• Smith LJ, Kalhan R, Wise RA, Sugar EA, Lima JJ, Irvin CG, Dozor AJ, Holbrook JT; American Lung Association Asthma Clinical Research Centers. Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: a randomized clinical trial. JAMA. 2015 May 26;313(20):2033-43. doi: 10.1001/jama.2015.5024.

Helpful Links

• ALA-ACRC Webpage

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: December 4, 2009
• First Submitted That Met QC Criteria: January 19, 2010
• First Posted (Estimate): January 20, 2010

Study Record Updates

• Last Update Posted (Estimate): January 14, 2016
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Asthma; Soy; Supplement; ACRC; SOYA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: ALAACRC-10; R01HL087987-01A2 (Other Identifier: NIH/NHLBI); R01 HL0088367-01A2 (Other Identifier: NIH/NHLBI)