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Study Summary
This trial will test if a daily treatment helps children aged 6 months to 5 with recurrent wheezing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have not had major surgery in the last 3 months.I have or had another type of cancer.I haven't had any systemic or steroid treatments in the last 4 weeks.My child is between 6 months and 5 years old.I do not have chronic respiratory diseases like tuberculosis or cystic fibrosis.I have significant lung, heart, liver, or kidney problems.I was born before reaching 34 weeks of pregnancy.My wheezing is caused by acid reflux.My breathing problems have been gone for at least a week.I haven't taken immunosuppressants, immunostimulants, or gamma globulins in the last 6 months.You have a known autoimmune disease.My child has recurrent wheezing and hasn't used ICS/LTRA much or uses it daily.I have known changes in my airways.You have HIV or a weakened immune system from a medical condition or treatment.
- Group 1: OM-85
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the aggregate figure of participants enrolled in this trial?
"288 individuals, who meet the trial's criteria for participation, must enroll in this research. Patients can register at Phoenix Children's Hospital of Tucson, Arkansas or The University of Arizona Medical Centre - University Campus located in Little Rock, California."
What adverse effects has OM-85 been connected with?
"OM-85 is deemed safe enough to be classified a "2" on our ranking scale, as there are preliminary evidence of its safety but none regarding efficacy."
How many participating locations are currently conducting this trial?
"At present, 28 clinical trial sites are recruiting participants for this medical study. These include Tucson, Little Rock and Bakersfield as well as other cities across the country. In order to minimise travel requirements, it is advisable that patients find a nearby clinic in which they can partake."
Is there capacity for additional enrollees in this trial?
"Indeed, clinicaltrials.gov's data says that this medical experiment is actively seeking enrolment from participants. It was initially posted on June 20th 2023 and has been recently updated on July 27th 2023. The study needs 288 patients to be recruited across 28 different healthcare locations."
Does the research permit seniors to participate?
"This trial is recruiting patients aged between 6 months and 72 months. Additionally, there are 169 studies available for minors under 18 years old and 899 studies open to seniors over 65."
Are there any limitations to who can participate in this clinical research?
"This clinical trial is aiming to enrol two-hundred and eighty eight participants who have asthma aged between 6 months and 5 years old. To be eligible, children must possess the following prerequisites: Up-to-date vaccinations against respiratory viruses as per CDC regulations, a history of at least 2 wheezing episodes with 1 being severe (or 3 leading to an unscheduled visit) in the past year for ICS/LTRA naive patients or intermittent users; those on daily controller therapy need one such episode in that period, written informed consent from parents/guardians before screening begins and no symptoms present within 1 week prior to enrollment"
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