140
Participants
Start Date
June 30, 2010
Primary Completion Date
October 31, 2010
Study Completion Date
October 31, 2010
Placebo nasal spray
1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase.
Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ)
"Treatment assignment was randomized with stratification by sex and age group (\>=2 to \<6, \>=6 to \<12 years old).~* For children who were \>=2 to \<6 years old, 1 spray/nostril (110 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase.~* For children who were \>=6 yrs to \<12 years old, either 1 spray/nostril (110 µg TAA-AQ) or 2 sprays/nostril (220 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase."
Placebo nasal spray
"Treatment assignment was randomized with stratification by sex and age group (\>=2 to \<6, \>=6 to \<12 years old).~* For children who were \>=2 to \<6 years old, 1 spray/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase.~* For children who were \>= 6 yrs to \<12 years old, either 1 spray/nostril or 2 sprays/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase."
Claritin® Syrup
Children's Claritin® Syrup \[5 mg of loratadine per 5 mL\] could be taken orally for the relief of AR symptoms throughout the study on an as needed basis, according to the Food and Drug Administration-approved manufacturer's label.
Investigational Site Number 840008, Raleigh
Investigational Site Number 840002, Spartanburg
Investigational Site Number 840006, Stockbridge
Investigational Site Number 840010, Plymouth
Investigational Site Number 840001, Omaha
Investigational Site Number 840005, San Antonio
Investigational Site Number 840003, Cypress
Investigational Site Number 840007, North Dartmouth
Lead Sponsor
Sanofi
INDUSTRY