AsthmaPhase 4SOYANCT01052116
The Study of Soy Isoflavones in Asthma
A Phase 4 study testing Soy isoflavone supplement in people with Asthma, run by American Lung Association Asthma Clinical Research Centers at 18 sites in United States.
Trial summary
The trial is designed to study the effects of soy supplements on asthma control. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Soy isoflavone supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 386 participants
- Where
- 18 sitesUnited States
- Study dates
- Mar 2010to Aug 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Vermont Lung Center at the University of Vermont
Burlington, Vermont, 05405
Northwestern Memorial Hospital
Chicago, Illinois, 60612
Davis Heart and Lung Research Institute
Columbus, Ohio, 43210
National Jewish Health
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Nemours Children's Clinic
Jacksonville, Florida, 32207
University of Missouri, Kansas City School of Medicine
Kansas City, Missouri, 64108
University of Miami School of Medicine
Miami, Florida, 33136
North Shore - Long Island Jewish Health System
New Hyde Park, New York, 11040
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
New York University School of Medicine
New York, New York, 10016
University of California, San Diego
San Diego, California, 92103
Washington University School of Medicine
St Louis, Missouri, 63110
University of South Florida College of Medicine
Tampa, Florida, 33613
University of Arizona
Tucson, Arizona, 85724
New York Medical College
Valhalla, New York, 10595
About this study
The trial is designed to study the effects of soy supplements on asthma control.
Read the 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
- Being tested
- Soy isoflavone supplement, Placebo
- Keywords
- Asthma, Soy, Supplement, ACRC, SOYA
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy isoflavone supplementDrug
Also called Soy supplement
Oral soy isoflavone supplement (100 mg/day)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Soy Isoflavone | Active comparator | Oral isoflavone supplement (100 mg/day) Receives: Drug: Soy isoflavone supplement |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to 24 Weeks for FEV1
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Lung Association Asthma Clinical Research Centers
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Robert A. Wise, M.D., American Lung Association Asthma Clinical Research Centers
- Investigators
- Lewis J Smith, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052116
- Sponsor's protocol ID
- ALAACRC-10
- Other IDs
- R01HL087987-01A2, R01 HL0088367-01A2
- Acronym
- SOYA
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2009
- Last updated
- 14 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 26010632Kaminsky 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.
PubMed 37536444
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Soy Isoflavones in Asthma
- ClinicalTrials.gov ID
- NCT01052116
- Acronym / sponsor ID
- SOYA / ALAACRC-10
- Conditions
- Asthma
- Keywords
- Asthma, Soy, Supplement, ACRC, SOYA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- American Lung Association Asthma Clinical Research CentersUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Posted 14 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy Isoflavone | Active comparator | Drug: Soy isoflavone supplementOral isoflavone supplement (100 mg/day) |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Age 12 or older
- Physician diagnosed asthma
- Poor asthma control (at least one of the following)
- Smoking status
Key exclusion criteria (28 listed)
- Pulmonary function
- Other major chronic illnesses
- Medication use
- Use of an investigational treatment in the previous 30 days
- "Drug" allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy isoflavone supplementAlso: Soy supplementOral soy isoflavone supplement (100 mg/day) | Drug | Soy Isoflavone |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Mean Change From Baseline to 24 Weeks for FEV1
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26010632Smith 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.
- Derived from this study: PubMed 37536444Kaminsky 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.
- ALA-ACRC WebpageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis J Smith, MD principal investigator
Northwestern University
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Soy isoflavone supplement in people with Asthma, run by American Lung Association Asthma Clinical Research Centers at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline to 24 Weeks for FEV1 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01052116, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.