Asthma INFANT Study – Phase III

Individualized Therapy For Asthma in Toddlers

Protocol Description

The goals of this multi-center study are to find out if one of several asthma treatments involving a combination of study drugs works better than another in toddlers, and to see if there are factors that can help doctors predict which treatment will work better for different children based on observable characteristics or biomarkers.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting preschool children of both genders, ages 1 through 4, who have been diagnosed with asthma.
Boys and Girls: Ages 12 to 59 months (1 through 4 years of age)

Note: Participation requires registration in the AsthmaNet research database and simultaneous participation in the AVICA study.

Participants will be prescribed a course of study medications to be taken daily and as needed. Placebos will be used in specific instances. All participants will follow a trio of 16-week programs in which, either A) a daily study inhaler will be active, B) a daily oral medication will be active, or C) a daily study inhaler with albuterol will be active. A 2- to 8-week “run-in” (trial) period will precede the 3 sequences to help with participant qualification.
Visits: 8
Duration: 50-56 weeks

Status: Open to Enrollment

Source(s) of Support
National Heart, Lung and Blood Institute (NHLBI)

Additional Resources
Study Description at National Institutes of Health

Primary Investigator(s)

Fernando Holguin, MD

Contact Information

For information or to enroll, please contact the Pulmonary Research team at 1-877-296-9026.

Last Update
April 21, 2014
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Last Update
April 21, 2014