The Study of Soy Isoflavones in Asthma (SOYA)

December 10, 2015 updated by: Robert A. Wise, M.D., American Lung Association Asthma Clinical Research Centers
The trial is designed to study the effects of soy supplements on asthma control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
386

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean Change From Baseline to 24 Weeks for FEV1
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
American Lung Association Asthma Clinical Research Centers

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lewis J Smith, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALAACRC-10
  • R01HL087987-01A2 (Other Identifier: NIH/NHLBI)
  • R01 HL0088367-01A2 (Other Identifier: NIH/NHLBI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings