Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis
Condition: Rhinitis, Allergic, Perennial and/or Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Placebo nasal spray; Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ); Placebo nasal spray; Claritin® Syrup
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase.; 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.; 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.; 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.
Intervention MeSH terms: Loratadine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment