The Study of Soy Isoflavones in Asthma

Asthma Clinical Trial

— SOYA  

Official title:

The Study of Soy Isoflavones in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052116
• Other study ID #: ALAACRC-10
• Secondary ID: R01HL087987-01A2
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2009
• Last updated: December 10, 2015
• Start date: March 2010
• Est. completion date: August 2012

Study information

• Verified date: December 2015
• Source: American Lung Association Asthma Clinical Research Centers
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Soy isoflavone supplement
Oral soy isoflavone supplement (100 mg/day)
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Vermont Lung Center at the University of Vermont	Burlington	Vermont
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Davis Heart and Lung Research Institute	Columbus	Ohio
United States	National Jewish Health	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	University of Missouri, Kansas City School of Medicine	Kansas City	Missouri
United States	University of Miami School of Medicine	Miami	Florida
United States	North Shore - Long Island Jewish Health System	New Hyde Park	New York
United States	Louisiana State University Health Sciences Center	New Orleans	Louisiana
United States	New York University School of Medicine	New York	New York
United States	University of California, San Diego	San Diego	California
United States	Washington University School of Medicine	St. Louis	Missouri
United States	University of South Florida College of Medicine	Tampa	Florida
United States	University of Arizona	Tucson	Arizona
United States	New York Medical College	Valhalla	New York

Sponsors (3)

Lead Sponsor	Collaborator
American Lung Association Asthma Clinical Research Centers	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 as — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline to 24 Weeks for FEV1		24 weeks	No

External Links

•   ALA-ACRC Webpage