Is NCT05667701 recruiting in Chicago, IL?

Yes, NCT05667701 is currently recruiting participants at its Chicago, IL location. This childhood asthma clinical trial is actively enrolling qualified participants.

How do I join the childhood asthma clinical trial in Chicago?

To join this clinical trial in Chicago, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Chicago clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Childhood Asthma Clinical Trial in Chicago, IL

About This Childhood Asthma Study in Chicago

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 lif

Sponsor: Rajesh Kumar

Who Can Participate

Inclusion Criteria

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

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.

Exclusion Criteria

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).

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).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chicago?

Yes, this clinical trial (NCT05667701) has an active research site in Chicago, IL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Childhood Asthma Treatment Options in Chicago, IL

If you're searching for childhood asthma treatment options in Chicago, IL, this clinical trial (NCT05667701) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chicago research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced childhood asthma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all childhood asthma clinical trials near you to find additional studies recruiting in your area.

Childhood Asthma Clinical Trial in Chicago, IL

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