The Study of Soy Isoflavones in Asthma

NCT ID: NCT01052116

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-08-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Soy Isoflavone

Oral isoflavone supplement (100 mg/day)

Group Type: ACTIVE_COMPARATOR

Soy isoflavone supplement

Intervention Type: DRUG

Oral soy isoflavone supplement (100 mg/day)

Placebo

Matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Soy isoflavone supplement

Oral soy isoflavone supplement (100 mg/day)

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Soy supplement

Eligibility 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

American Lung Association Asthma Clinical Research Centers

OTHER

Sponsor Role: lead

Responsible Party

Robert A. Wise, M.D.

Director of Data Coordinating Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lewis J Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

University of Arizona

Tucson, Arizona, United States

University of California, San Diego

San Diego, California, United States

National Jewish Health

Denver, Colorado, United States

Nemours Children's Clinic

Jacksonville, Florida, United States

University of Miami School of Medicine

Miami, Florida, United States

University of South Florida College of Medicine

Tampa, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States

University of Missouri, Kansas City School of Medicine

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

North Shore - Long Island Jewish Health System

New Hyde Park, New York, United States

New York University School of Medicine

New York, New York, United States

New York Medical College

Valhalla, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Davis Heart and Lung Research Institute

Columbus, Ohio, United States

Baylor College of Medicine

Houston, Texas, United States

Vermont Lung Center at the University of Vermont

Burlington, Vermont, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 26010632 (View on PubMed)

Kaminsky DA, He J, Henderson R, Dixon AE, Irvin CG, Mastronarde J, Smith LJ, Sugar EA, Wise RA, Holbrook JT. Bronchodilator response does not associate with asthma control or symptom burden among patients with poorly controlled asthma. Respir Med. 2023 Nov;218:107375. doi: 10.1016/j.rmed.2023.107375. Epub 2023 Aug 1.

Reference Type: DERIVED

PMID: 37536444 (View on PubMed)

Related Links

http://www.cctrials.org/alaacrc

ALA-ACRC Webpage

Other Identifiers

R01HL087987-01A2

Identifier Type: OTHER

Identifier Source: secondary_id

R01 HL0088367-01A2

Identifier Type: OTHER

Identifier Source: secondary_id

ALAACRC-10

Identifier Type: -

Identifier Source: org_study_id