Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis

PHASE4CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
Rhinitis, Allergic, Perennial and/or Seasonal
Interventions
DRUG

Placebo nasal spray

1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase.

DRUG

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."

DRUG

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."

DRUG

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.

Trial Locations (8)

27607

Investigational Site Number 840008, Raleigh

29307

Investigational Site Number 840002, Spartanburg

30281

Investigational Site Number 840006, Stockbridge

55441

Investigational Site Number 840010, Plymouth

68144

Investigational Site Number 840001, Omaha

78229

Investigational Site Number 840005, San Antonio

90630

Investigational Site Number 840003, Cypress

02747

Investigational Site Number 840007, North Dartmouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY