NCT01272635

Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids.

Azithromycin for Preventing the Development of Upper Respiratory Tract Illness Into Lower Respiratory Tract Symptoms in Children and Oral Corticosteroids for Treating Episodes of Significant Lower Respiratory Tract Symptoms in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 12 Months – 71 Months
• Healthy volunteers: Not accepted

Summary

This protocol is comprised of two separate, but linked, clinical trials for treating preschool-aged children with recurrent severe episodes of wheezing. The first study (APRIL) will try to prevent wheezing illness from developing using azithromycin. If a wheezing illness does occur, the second trial (OCELOT) will try to decrease the severity of symptoms using oral corticosteroids.

Detailed description

Preschool aged children often have severe bouts of coughing and/or wheezing that lead to visits to the doctor's office, urgent care, emergency room and often hospitalization. APRIL-OCELOT is a randomized, double-blind, placebo controlled study in 600 preschool children with a history of significant wheezing episodes in the year prior to enrollment. All children enter the APRIL portion of the study, which will compare azithromycin to placebo, given for 5 days during the early signs of an upper respiratory tract illness, for preventing the development of lower respiratory tract symptoms. APRIL is a 78 week study, but participation will end earlier if the child requires a fourth course of APRIL treatment or develops significant lower respiratory tract symptoms. Only those children who develop significant lower respiratory tract symptoms during APRIL will enter the OCELOT portion of the study, which will compare oral corticosteroid to placebo for treating lower respiratory tract symptoms as measured by the Pediatric Respiratory Assessment Measure (PRAM). OCELOT participation will be complete after 14 days. Children may not reenter APRIL after completing OCELOT.

Conditions

• Asthma
• Wheezing

Interventions

Type	Name	Description
DRUG	Azithromycin	Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
DRUG	Prednisolone	Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
OTHER	Placebo Azithromycin	Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
DRUG	Placebo Prednisolone	Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day

Timeline

• Start date: 2011-03-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2011-01-10
• Last updated: 2016-12-28
• Results posted: 2016-12-28

Locations

16 sites across 1 country: United States