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
Intervention: Placebo nasal spray; Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ); Placebo nasal spray; Claritin® Syrup
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        Participants who met the following criteria were eligible for this study:

        Inclusion Criteria:

          -  History of AR documented by the investigator, as follows:

               -  At least a 1-year clinical history (6-month history if the participant was >= 2
                  to < 4 years of age) of perennial allergic rhinitis (PAR); or a clinical history
                  of seasonal allergic rhinitis (SAR) over 2 seasons and

               -  positive skin test (prick or intradermal) to a seasonal or perennial allergen
                  that was present in the participant's environment at time of screening.

          -  Written informed consent and ability of parent/legal guardian of the participant to
             give a written informed consent before any study related procedures. Participants >=7
             years of age (or younger according to the governing institutional review board [IRB])
             had to provide a signed assent form

        Exclusion Criteria:

          -  Concomitant medical condition that might have interfered with the administration of a
             nasal spray, including anatomical abnormalities of the nose, face (eg, polyposis,
             markedly deviated septum)

          -  Presence of any active, untreated, or clinically significant musculoskeletal,
             endocrinologic, gastrointestinal, hepatic, respiratory, cardiovascular, or
             neurological condition that might have interfered with the study

          -  Any conditions or treatment that might have affected the HPA axis or the plasma
             cortisol assay, including but not limited to:

               -  Documented disorder involving the hypothalamus, pituitary, or adrenal gland

               -  Current use of serotonergic, dopaminergic, adrenergic, cholinergic agonists and
                  antagonists, opiates, immunomodulatory, hormonal drugs, and lipid-lowering agents

               -  Treatment with systemic corticosteroids (oral, intravenous, intramuscular, or
                  intra-articular) within 3 months prior to Visit 1

               -  Treatment with systemic corticosteroids for > 2 courses received up to 1 year
                  before Visit 1 was exclusionary. Up to 2 courses of systemic corticosteroids,
                  each course not exceeding 14 days, up to 1 year before Visit 1 was allowed

               -  Treatment with inhaled, intranasal, or high-potency topical corticosteroids
                  within 6 weeks of Visit 1

               -  History of hospitalization due to asthma within 1 year before screening.
                  Participants with mild asthma that was well-controlled without the use of inhaled
                  corticosteroids within 6 weeks prior to Visit 1 were eligible for the study

          -  Any clinically significant (as determined by the investigator) abnormal laboratory
             test at Visit 1

          -  Morning serum cortisol outside the reference range at Visit 1

          -  Any of the following missing serum cortisol samples from the Visit-2 collection: first
             sample (before administration of investigational product), 20-hour sample, 24-hour
             sample, or any 2 consecutive samples

          -  Any medical condition where use of corticosteroids might have been contraindicated or
             could have led to disease exacerbation (eg, glaucoma, cataract, ocular herpes simplex,
             tuberculosis, growth retardation)

          -  History of hypersensitivity to corticosteroids or to the rescue medication,
             investigational product, or to any of their excipients

          -  Unresolved upper respiratory tract infection, sinus infection, or nasal candidiasis
             (ie, symptomatic or under treatment) within the last 2 weeks prior to Visit 1 and
             Visit 3

          -  Females of childbearing potential not protected by effective contraceptive method of
             birth control or were unwilling to abstain from sexual activity and/or, were unwilling
             or unable to test for pregnancy. Only female adolescent with onset of menses were to
             be checked by serum pregnancy test at Visit 1

          -  Pregnant female adolescent (who tested positive for pregnancy at Visit 1) The above
             information was not intended to contain all considerations relevant to potential
             participation in a clinical trial.