DOES YOUR CHILD WHEEZE? JOIN OUR STUDY LOOKING AT A TREATMENT FOR ASTHMA AND BREATHING PROBLEMS!

K
Kirsten Kloepfer, MD

Primary Investigator

DOES YOUR CHILD WHEEZE?  JOIN OUR STUDY LOOKING AT A TREATMENT FOR ASTHMA AND BREATHING PROBLEMS!
Not Recruiting
2-3 years
All
Phase N/A
2 Locations

Brief description of study

Does your child experience breathing difficulties due to asthma, wheezing or allergies?

Researchers at Indiana University School of Medicine and Riley Children's Hospital are investigating a treatment for asthma in young children to determine if it:

  1. Helps prevent asthma as children grow older;
  2. Lessens the severity of breathing problems;
  3. Stops young kids from developing new allergies or reduce existing allergies;
  4. Decreases wheezing during and after the treatment period.
 

Detailed description of study

Who Is Eligible
  • Children 2-3 years of age
  • Family history of asthma, allergies or eczema
  • Had wheezing symptoms in the past year
What Is Involved
Children taking part in this study will be placed by random, like a flip of a coin, into one of two groups: a group that will receive the study drug Omalizumab (also known as Xolair) or a group that will receive a placebo.

Participants will receive this medicine by injection every 4 weeks for 2 years and will then be followed for an additional 2 years:
 
Years 1 and 2
  • Receive an injection of either the study drug, Omalizumab, or placebo every 4 weeks.
Years 3 and 4
  • Attend study visits every 4 months for clinical assessment, management of respiratory symptoms, and completion of study questionnaires
  • Participate in monthly phone calls to assess how your child is doing.
  • No injections will take place during years 3 and 4
Study visits will take place at Riley Children’s Clinical Research Center in Indianapolis.
 
Participants will be compensated for their time and could receive up to $2,560 for completed study visits and telephone calls.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: asthma,eczema,allergy,allergies
  • Age: Between 2 Years - 3 Years
  • Gender: All

Eligibility Criteria:
  • Children 2-3 years of age
  • Family history of asthma, allergies or eczema
  • Had wheezing symptoms in the past year
Additional Information:For more information about the PARK (Preventing Asthma in HIgh Risk Kids) Study, please visit the study website at: www.Parkstudy.org

Updated on 01 Aug 2024. Study ID: 1911077578

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center