Conditions: Asthma Wheezing
Keywords: Asthma Wheezing Respiratory Tract Illness Azythromycin Prednisolone Preschool-age
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 607
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Azithromycin intervention 2: Prednisolone intervention 3: Placebo Azithromycin intervention 4: Placebo Prednisolone
Intervention descriptions: intervention 1: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day intervention 2: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day intervention 3: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day intervention 4: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day

Protocol document: