WheezingPhase 2SIRANCT05667701
Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
A Phase 2 study testing Soy isoflavone in people with Wheezing and Asthma in Children, run by Rajesh Kumar at 2 sites in United States.
Trial summary
The goal of this clinical trial is to compare soy isoflavones to placebo in children who at risk of asthma and have a genetic variation which results in them making more of a pro-inflammatory protein, plasminogen activator inhibitor-1. Read more about this study
- Who is it for?
- Ages 2 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Wheezing, Asthma in Children
- What is being tested?
- Soy isoflavone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Sep 2024to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 2 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent/guardian must be an adult (≥18 years of age) and able to understand and provide informed consent.
- Age: Term infants (≥37 weeks gestational age) less than 12 months of age at recruitment
- High risk of asthma: As determined by one or more of the following:
- A history of uni- or bi-parental asthma with onset in childhood by parent self report, OR
- Uni- or bi-parental asthma with onset after childhood along with the presence of one or more other comorbid atopic condition including allergic rhinitis, atopic dermatitis, or food allergy, OR
- atopic dermatitis in the child determined by parent report of a physician diagnosis
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- Genotype: Either homozygous or heterozygous for the PAI-1 risk allele (i.e. 4G4G or 4G5G).
- Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the SIRA Manual of Operations (MOP).
- Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion.
Who cannot join
- 1. Inability or unwillingness of a parent or guardian to give written informed consent or comply with study protocol.
- Parents who will not include either a puree or some form of bottle feeding such that the infant would be able to take the investigational product in a puree or a liquid (expressed breast milk, supplemental formula, or a small amount of water).
- Currently on a soy based formula.
- Breastfeeding mothers who are taking soy supplements or soy enriched foods more than 2 times a week and will not stop this level of ingestion while breastfeeding.
- On treatment for recurrent wheezing such as regular inhaled steroids.
- The infant may not have the following specific contraindications: known congenital thyroid disease, or a history of estrogen sensitive clinically relevant mutations in the family (such as BRCA1).
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- Medication use
- Maternal use of tamoxifen in pregnancy or if breastfeeding
- Use of immunomodulatory medications such at methotrexate, mycophenolate, azathioprine, or other immunomodulatory agent in the mother if breastfeeding or in the infant.
- Use of another investigational agent in the last 30 days prior to randomization.
- Current, parent reported, diagnosis of mental illness or current, diagnosed or self-reported drug or alcohol abuse (in the primary caregiver) that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Known allergy to soy protein (either by reported allergy or skin testing to soy prior to randomization) or reported allergy to NovaSoy, from which the investigational product is compounded.
- The infant is currently participating in another asthma-related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to enrollment.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
- Infant requiring intubation prior to screening.
- Infant requiring > 3 hospitalizations for asthma symptoms/ wheezing illness prior to screening.
- Infant requiring > 3 five day bursts of oral steroid at least 14 days apart from each other prior to screening.
- Any chronic condition requiring use of systemic corticosteroids or another immunomodulating agent at screening or before randomization, and during the course of the study.
- Non-adherence:
- Inability / unwillingness of the parents to induce the infant to swallow study medication
- Unwillingness of the parents to allow the staff to perform baseline measurements
- Living with a foster parent as a ward of the state.
- Caregiver does not have access to a phone (needed for scheduling appointments or responding to questionnaires).
- Plan(s) for the family to move from the area during the study period.
- The infant's caretaker does not primarily speak English or Spanish.
- In order to be eligible to continue in the study following screening visit A (V1) , an individual must meet all of the following additional randomization criteria:
- Must be ≥4 months and <12 months of age at randomization
- Must have either 4G/4G or 4G/5G genotype
- Cannot have had a severe wheezing exacerbation requiring ICU admission between screening (V1) and randomization (V3)
- Cannot have had more than two wheezing / "asthma" episodes (separated from each other by at least 14 days), each requiring at least a 5 day course of oral steroids in the time between screening visit A (V1) and randomization (V3).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611
Rajesh Kumar, MD, 312 227 6010
Rajesh Kumar, MD
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Michelle Kominarek, MD
About this study
The goal of this clinical trial is to compare soy isoflavones to placebo in children who at risk of asthma and have a genetic variation which results in them making more of a pro-inflammatory protein, plasminogen activator inhibitor-1. The main questions this trail seeks to answer is: will soy isoflavones decrease the proportion of infants with aT2 high endotype at the end of treatment, and secondarily decrease the number of wheezing episodes in these children when given in the first year of life. Participants will be asked to ingest soy isoflavone or placebo twice daily mixed into a liquid or puree vehicle for 7 months from randomization. There will be 3 mandatory in-person visits, and 6 virtual visits in the first year. There will also be 11 monthly questionnaires and 1 in person visit in the observation year. Participants will have 4 nasal swabs, 3 blood draws, and also provide 4 stool samples over the course of the study.
Read the detailed description
The study is designed as a single site, randomized, quadruple-masked, placebo-controlled, parallel group clinical trial. We will enroll 65 high risk infants with the PAI-1 risk genotype, who are less than 12 months of age, and will be randomized to one of two treatment groups. The treatment groups will be either oral isoflavone supplement (at doses similar to that seen in soy formula) or a matching placebo .
Screening will occur throughout each year, with genotyping occurring at the first visit, and assumption of care of individuals with the risk genotype after randomization. There will be a study run in period up to 12 months at which time subjects will be randomized. The treatment period will run for 7 months for each participant, and will have a 1 year observation period after the end of treatment.
At randomization, the investigators will assume the care of the children for all wheezing illnesses. The subjects will have either virtual or in person visits for each of the next 6 visits, followed by an in-person visit at the end of treatment. The subjects will also come in for in-person visits at times of viral illnesses. At randomization, end of treatment, viral illness, and end of study the subjects will have nasal swabs and nasosorption carried out. Blood draws will occur at randomization, end of treatment, and the end of study visit. Stool will be collected for microbiome assessment at randomization, the 3rd or 4th month of treatment, the end of treatment, and the end of the study at the end of the observation year. The study will also measure infant pulmonary function using a wearable device to assess expiratory variability overnight. This will be measured at randomization, viral illness, end of treatment, and at the end of the study after the 1 year observation period. The treatment period will run for 7 months for each participant, with a 1 year observation period after this.
- Conditions
- Wheezing, Asthma in Children
- Being tested
- Soy isoflavone, matching placebo
- Keywords
- wheezing, soy isoflavone, PAI-1
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy isoflavoneDrug
Also called Novasoy
Soy isoflavone supplement (Novasoy) that contains isoflavones (genistein, daidzein, glycetein) given at a dose of genistein aglycone equivalents to provide the genistein dosing of 22.6 mg/day for children aged 2-10 months, and 30.3 mg/day children aged 10-24 months
matching placeboDrug
Also called placebo
A matching placebo also administered twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Soy isoflavone | Experimental | Soy isoflavone powder dosed in puree or liquid twice daily Receives: Drug: Soy isoflavone |
| Placebo | Placebo comparator | Matching placebo powder dosed in puree or liquid twice daily Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
T2 endotype
This measure is determined by the proportion of subjects designated as having a T2 high endotype at the end of the treatment period (week 32) in the soy genistein vs placebo treatment arms.
Measured: From week 0 (randomization) to week 30 (end of treatment)
Secondary outcomes (3)
wheezing episodes
Number of episodes of wheezing - based on numbers of reported episodes of illness associated with wheezing over the treatment period.
Measured: 7 months
Expiratory variability index
Infant pulmonary function assessed by measurement of the Expiratory Variability Index change from baseline
Measured: from week 0 (randomization) to week 30 (end of treatment) and from week 0 (randomization) to week 88 (end of study)
safety and tolerability
Number and grade of adverse events by treatment arm
Measured: from week 0 (randomization) to week 88 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start18 Sep 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WheezingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- genotype stratified, quadruple blinded randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajesh Kumar
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, University of South Florida, University of Colorado, Denver, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor-investigator, Rajesh Kumar, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Rajesh Kumar, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667701
- Sponsor's protocol ID
- CAUSE-LCH-001
- Other IDs
- U01AI160018-01
- Acronym
- SIRA
- Status last verified
- Nov 2025
- First submitted
- 20 Dec 2022
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: At present, the investigators plan to make deidentified data available as per NIH policy at 3 years after the completion of the study. This will not include any identifying information but will include all the primary outcome data and the participant individual level data that were included in the analyses including relevant covariates. It is planned that the investigators will use AccessClinicalData@NIAID for this purpose.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
- ClinicalTrials.gov ID
- NCT05667701
- Acronym / sponsor ID
- SIRA / CAUSE-LCH-001
- Conditions
- Wheezing, Asthma in Children
- Keywords
- wheezing, soy isoflavone, PAI-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Rajesh KumarUniversity, hospital or other
- Collaborators
- Northwestern University, University of South Florida, University of Colorado, Denver, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare soy isoflavones to placebo in children who at risk of asthma and have a genetic variation which results in them making more of a pro-inflammatory protein, plasminogen activator inhibitor-1. The main questions this trail seeks to answer is: will soy isoflavones decrease the proportion of infants with aT2 high endotype at the end of treatment, and secondarily decrease the number of wheezing episodes in these children when given in the first year of life. Participants will be asked to ingest soy isoflavone or placebo twice daily mixed into a liquid or puree vehicle for 7 months from randomization. There will be 3 mandatory in-person visits, and 6 virtual visits in the first year. There will also be 11 monthly questionnaires and 1 in person visit in the observation year. Participants will have 4 nasal swabs, 3 blood draws, and also provide 4 stool samples over the course of the study.
Detailed description
The study is designed as a single site, randomized, quadruple-masked, placebo-controlled, parallel group clinical trial. We will enroll 65 high risk infants with the PAI-1 risk genotype, who are less than 12 months of age, and will be randomized to one of two treatment groups. The treatment groups will be either oral isoflavone supplement (at doses similar to that seen in soy formula) or a matching placebo .
Screening will occur throughout each year, with genotyping occurring at the first visit, and assumption of care of individuals with the risk genotype after randomization. There will be a study run in period up to 12 months at which time subjects will be randomized. The treatment period will run for 7 months for each participant, and will have a 1 year observation period after the end of treatment.
At randomization, the investigators will assume the care of the children for all wheezing illnesses. The subjects will have either virtual or in person visits for each of the next 6 visits, followed by an in-person visit at the end of treatment. The subjects will also come in for in-person visits at times of viral illnesses. At randomization, end of treatment, viral illness, and end of study the subjects will have nasal swabs and nasosorption carried out. Blood draws will occur at randomization, end of treatment, and the end of study visit. Stool will be collected for microbiome assessment at randomization, the 3rd or 4th month of treatment, the end of treatment, and the end of the study at the end of the observation year. The study will also measure infant pulmonary function using a wearable device to assess expiratory variability overnight. This will be measured at randomization, viral illness, end of treatment, and at the end of the study after the 1 year observation period. The treatment period will run for 7 months for each participant, with a 1 year observation period after this.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- genotype stratified, quadruple blinded randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Soy isoflavone | Experimental | Drug: Soy isoflavoneSoy isoflavone powder dosed in puree or liquid twice daily |
| Placebo | Placebo comparator | Drug: matching placeboMatching placebo powder dosed in puree or liquid twice daily |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Parent/guardian must be an adult (≥18 years of age) and able to understand and provide informed consent.
- Age: Term infants (≥37 weeks gestational age) less than 12 months of age at recruitment
- High risk of asthma: As determined by one or more of the following:
- Genotype: Either homozygous or heterozygous for the PAI-1 risk allele (i.e. 4G4G or 4G5G).
- Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the SIRA Manual of Operations (MOP).
Key exclusion criteria (30 listed)
- 1. Inability or unwillingness of a parent or guardian to give written informed consent or comply with study protocol.
- Parents who will not include either a puree or some form of bottle feeding such that the infant would be able to take the investigational product in a puree or a liquid (expressed breast milk, supplemental formula, or a small amount of water).
- Currently on a soy based formula.
- Breastfeeding mothers who are taking soy supplements or soy enriched foods more than 2 times a week and will not stop this level of ingestion while breastfeeding.
- On treatment for recurrent wheezing such as regular inhaled steroids.
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 isoflavoneAlso: NovasoySoy isoflavone supplement (Novasoy) that contains isoflavones (genistein, daidzein, glycetein) given at a dose of genistein aglycone equivalents to provide the genistein dosing of 22.6 mg/day for children aged 2-10 months, and 30.3 mg/day children aged 10-24 months | Drug | Soy isoflavone |
| matching placeboAlso: placeboA matching placebo also administered twice daily. | Drug | Placebo |
Primary outcome
T2 endotype
Time frame: From week 0 (randomization) to week 30 (end of treatment)
This measure is determined by the proportion of subjects designated as having a T2 high endotype at the end of the treatment period (week 32) in the soy genistein vs placebo treatment arms.
3 secondary outcomes
wheezing episodes
Time frame: 7 months
Expiratory variability index
Time frame: from week 0 (randomization) to week 30 (end of treatment) and from week 0 (randomization) to week 88 (end of study)
safety and tolerability
Time frame: from week 0 (randomization) to week 88 (end of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Yes. At present, the investigators plan to make deidentified data available as per NIH policy at 3 years after the completion of the study. This will not include any identifying information but will include all the primary outcome data and the participant individual level data that were included in the analyses including relevant covariates. It is planned that the investigators will use AccessClinicalData@NIAID for this purpose.
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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.
Rajesh Kumar, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Soy isoflavone in people with Wheezing and Asthma in Children, run by Rajesh Kumar at 2 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 9 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Godley, RN (312 227 6010, sgodley@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T2 endotype (time frame: From week 0 (randomization) to week 30 (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2025.