Clinical trial NCT01154153
Conditions: Rhinitis, Allergic, Perennial and/or Seasonal
Sponsor: Sanofi
Start date: 2010-06-01; Completion date: 2010-10-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg) and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA) axis function as measured by serum cortisol AUC(0-24 hr) in children (\>=2 to \<12 years old) with allergic rhinitis (AR).

Detailed description:
The study consisted of a run-in single-blind screening phase (prerandomization) followed by an approximately 6-week double-blind treatment phase (postrandomization).

Total study duration per participant lasted from 7.5 to 13 weeks and consisted of:

* Screening and single-blind phases (these 2 phases ran concurrently, prerandomization) for 8 to 24 days. During the screening phase participants were given a single-blind placebo nasal spray to enable them to practice their intranasal application technique once daily in the morning (1 actuation/nostril).
* Randomization to the double-blind treatment phase. Treatment assignment was randomized with stratification by sex and age group (\>=2 to \<6, \>=6 to \<12 years old).
* Double-blind treatment phase which lasted at least 42 days and ran up to 47 days. Participants were administered either TAA-AQ nasal spray or placebo nasal spray.
* An evaluation at the end of treatment 1-3 days after completion of the double-blind phase.

Arms: arm 1: * placebo during the screening phase and
* placebo during the treatment phase.

All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR. arm 2: * placebo during the screening phase and
* TAA-AQ (Nasacort AQ) during the treatment phase.

All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
Interventions: intervention 1: Placebo nasal spray intervention 2: Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ) intervention 3: Placebo nasal spray intervention 4: Claritin® Syrup
Intervention descriptions: intervention 1: 1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase. intervention 2: 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. intervention 3: 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. intervention 4: 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.

Protocol documents: