APRIL-OCELOT Study for Coughing/Wheezing Preschoolers – Phase III

Azithromycin for Preventing Development of Upper Respiratory Tract Illness into Lower Respiratory Tract Symptoms (APRIL) and Oral Corticosteroids for Treating Episodes of Significant LOwer respiratory Tract Symptoms in Children (OCELOT)

Protocol Description

The purpose of this multicenter research, which is being conducted through AsthmaNet, is to study two treatment plans that address severe bouts of coughing and/or wheezing in preschool aged children. One treatment plan, known as APRIL, will try to prevent bad coughing or wheezing by using the oral antibiotic azithromycin when early signs of respiratory illness (or a cold), are observed. The second treatment plan, OCELOT, will evaluate whether the oral corticosteroid prednisolone is effective at decreasing symptoms if an illness develops during APRIL treatment. AsthmaNet is a nationwide clinical research network created by the National Heart Lung and Blood Institute.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusions, this study is open to children of both genders, from ages 1 through 5, who are having repeated wheezing episodes, and who may also suffer from asthma.
Males: Ages 1 through 5 years (71 months)
Females: Ages 1 through 5 years (71 months)

Participants will be registered in the AsthmaNet Registry, and then evaluated for 14 to 28 days to determine if they qualify for the study, during which time parents will need to keep a daily diary of their participating child’s breathing symptoms. Qualifying participants will then be assigned to the APRIL study, with half randomly selected to take the study drug azithromycin, and half taking a placebo. Participants who develop significant lower respiratory tract symptoms during APRIL may be assigned to the OCELOT portion of the study. OCELOT randomly determines the prescription of either the OCELOT study drug prednisolone or a placebo, and evaluates results using the Pediatric Respiratory Assessment Measure. Physical examinations will be required at certain intervals, and parents are required to closely coordinate with the research team regarding changes in their child’s health. AsthmaNet’s nurse center also provides after-hours phone support.
Visits: Will vary based on individual experiences
Duration: About 1 year (56 weeks)

Status: Open to Enrollment

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

Additional Resources
Study Description at National Institutes of Health

Primary Investigator(s)

Fernando Holguin, MD

Contact Information

For information or to enroll, please contact:
Julianne Parente, BSN, RN

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