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The Study of Soy Isoflavones in Asthma (SOYA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01052116
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : January 14, 2016
Last Update Posted : January 14, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert A. Wise, M.D., American Lung Association Asthma Clinical Research Centers

Tracking Information
First Submitted Date  ICMJE December 4, 2009
First Posted Date  ICMJE January 20, 2010
Results First Submitted Date  ICMJE December 10, 2015
Results First Posted Date  ICMJE January 14, 2016
Last Update Posted Date January 14, 2016
Study Start Date  ICMJE March 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2015)
Mean Change From Baseline to 24 Weeks for FEV1 [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
  • Exhaled Nitric Oxide [ Time Frame: Every 4 weeks for 6 months ]
  • Asthma control as measured with the Juniper Asthma Control Questionnaire (ACQ) [ Time Frame: -4 weeks, 0 weeks, and every 4 weeks for 6 months ]
  • Asthma diary [ Time Frame: Daily for 6 months ]
  • Episodes of poor asthma control (EPAC) [ Time Frame: Every 4 weeks for 6 months ]
  • Increased use of bronchodilator rescue medicine over baseline [ Time Frame: Every 4 weeks for 6 months ]
  • Asthma Symptom Utility Index (ASUI) [ Time Frame: Every 4 weeks for 6 months ]
  • Asthma specific and generic health-related quality of life [ Time Frame: Every 4 weeks for 6 months ]
  • Airway reactivity as measured with methacholine challenge testing [ Time Frame: -4 weeks if necessary ]
  • Side effects and toxicity [ Time Frame: Every 4 weeks for 6 months ]
  • Genistein levels [ Time Frame: 0 weeks, 4 weeks, 24 weeks ]
  • Peripheral blood eosinophil counts [ Time Frame: 0 weeks, 4 weeks, 24 weeks ]
  • Interleukin-6 (IL-6) and C-Reactive Protein (CRP) [ Time Frame: 0 weeks, 4 weeks, 24 weeks ]
  • Urinary LTE4 levels [ Time Frame: 0 weeks, 4 weeks, 24 weeks ]
  • Genotyping to determine genetic determinants of soy isoflavone effects (optional for participation) [ Time Frame: 0 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study of Soy Isoflavones in Asthma
Official Title  ICMJE The Study of Soy Isoflavones in Asthma
Brief Summary The trial is designed to study the effects of soy supplements on asthma control.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Soy isoflavone supplement
    Oral soy isoflavone supplement (100 mg/day)
    Other Name: Soy supplement
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Soy Isoflavone
    Oral isoflavone supplement (100 mg/day)
    Intervention: Drug: Soy isoflavone supplement
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2015)
386
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2010)
380
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01052116
Other Study ID Numbers  ICMJE ALAACRC-10
R01HL087987-01A2 ( Other Identifier: NIH/NHLBI )
R01 HL0088367-01A2 ( Other Identifier: NIH/NHLBI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert A. Wise, M.D., American Lung Association Asthma Clinical Research Centers
Study Sponsor  ICMJE American Lung Association Asthma Clinical Research Centers
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Lewis J Smith, MD Northwestern University
PRS Account American Lung Association Asthma Clinical Research Centers
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP