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Omalizumab for Preventing Asthma in Kids (PARK Trial)
PARK Trial Summary
This trial is testing whether a drug can prevent asthma in kids aged 2-3. It's double-blind, meaning neither the participants nor the researchers know who's receiving the drug or the placebo.
PARK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPARK Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PARK Trial Design
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Who is running the clinical trial?
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- I have had more than 4 wheezing episodes in the last year.I have previously received allergy shots or biologic treatments.I am currently using a high-level asthma treatment.I've had wheezing or coughing at night that disturbed my sleep more than once in the last two weeks.I've used albuterol for symptoms more than once at night in the last two weeks.I needed oxygen for more than 5 days after birth.My IgE levels are not within the range for omalizumab treatment.I have had seizures caused by low oxygen during asthma attacks.Your blood platelet count is less than 150 x 10^9/L at the screening visit.I am unable to follow the study's required activities.I do not have major health issues like cystic fibrosis or a history of tuberculosis.I have not taken IVIG or immunosuppressants, except for corticosteroids.I have had 2-4 wheezing episodes in the last year.A close family member has or had asthma or allergies.I have been on a stable food allergy treatment not part of a trial for at least 2 months.I am between 2 and 4 years old.I've used albuterol for symptoms more than four days in the last two weeks.You have had serious allergic reactions in the past.I have been on a breathing machine for lung problems before.You were born before 34 weeks of pregnancy.I've had symptoms like wheezing or chest tightness that limited my activities in the last two weeks.I have needed steroids or was hospitalized for breathing problems in the last month.I've taken steroids for wheezing more than 3 times last year.You have a confirmed allergy to airborne allergens.
- 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
Are there other investigations concerning Active already in progress?
"Currently, 22 investigations analyzing Active are live with 6 of those experiments in Phase 3. Most trials for Active are being conducted at the Jerez de la Frontera location, but there is a total of 254 locations running tests on Active."
How many medical centers are engaged in this research trial?
"This research is recruiting individuals at Childrens Hospital Colorado in Aurora, Ohio, Cincinnati Children's Medical Centre in Cincinnati and Connecticut Children's Hospital in Hartford as well as thirteen additional medical centres."
Is this research actively recruiting participants?
"Data on clinicaltrials.gov shows this trial is still actively recruiting participants, having first been listed on 27th November 2018 and edited most recently on 13th January 2022."
To what extent does Active pose a risk to patients' well-being?
"With the current evidence, Active is assessed as a 2 on our team's 1-3 scale. This rating reflects that we have some data validating its safety but none confirming efficacy at this Stage 2 trial."
What medical complaints is Active typically administered to combat?
"Active can be utilized to mitigate symptoms caused by perennial aeroallergen reactivity and effectively manage the effects of inhaled corticosteroids, histamine h1 antagonists, non-sedating medications, and moderate asthma."
Is it possible to join this clinical research experiment?
"The trial is searching for a total of 200 individuals who have asthma and fall within the age range of 24 Months - 47 Months."
Is this investigation open to individuals over the age of 35?
"This clinical trial is open to children between two years old and almost four years old. An additional 119 studies are available for minors, while 211 trials are hosted specifically for senior citizens."
What is the scale of participation in this clinical research?
"To successfully conduct this clinical trial, 200 participants must meet the set criteria and join from locations such as Childrens Hospital Colorado in Aurora or Cincinnati Children's Hospital Medical Center."
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