Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Placebo; Placebo; TAA-AQ, Nasacort® AQ; Claritin®
Intervention description: Placebo to TAA-AQ was administered once at the study site in each nostril during the baseline/screening period to demonstrate intranasal IP administration; Placebo to TAA-AQ was administered intranasally once daily in each nostril during the double-blind period; 110 μg TAA-AQ was administered once daily intranasally (1 spray delivering 55 μg of TAA-AQ in each nostril) during the double-blind treatment period; Participants were provided Children's Claritin® Syrup (5 mg of loratadine per 5 mL), as rescue medication for the relief of allergic rhinitis (AR) symptoms, and could be used throughout the study on an as needed basis according to the Food and Drug Administration-approved manufacturer's label
Intervention MeSH terms: Loratadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 299.0
Sex: All
Minimum age: 3 Years
Maximum age: 9 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to characterize the difference in prepubescent growth
      velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with
      triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo
      (NASACORT® AQ placebo group) for 12-months.

      The secondary objectives were to compare the following in prepubertal participants treated
      with TAA nasal spray versus placebo:

        -  the 24-hour urinary free cortisol levels and the cortisol/creatinine ratio (to measure
           the Hypothalamic-Pituitary Adrenal [HPA] axis function)

        -  the rate of treatment-emergent-adverse-events (TEAE)

        -  global efficacy rated by the investigator and the participant separately

        -  the rate of use of rescue medication during the study
    

Eligibility criteria:

        Participants meeting the following eligibility criteria were enrolled.

        Inclusion criteria:

          1. Male participants [3 years to <= 9 years + 0 days old] at Visit 1 and no older than [9
             years + 120 days] at Visit 3; and, female participants [3 years to <= 8 years + 0 days
             old] at Visit 1 and no older than [8 years + 120 days] at Visit 3: all sexually
             prepubertal (ie, Stage 1 of Tanner Classification of sexual maturity) at Visit 1 and
             Visit 3. A 5-day extension to the age upper bound was permitted under certain
             circumstances to enable scheduling of Visits 1 and 3

          2. At least a one year history of PAR as assessed and documented by the investigator
             (with or without seasonal allergic rhinitis [SAR])

          3. Positive skin test (prick or intradermal) to a perennial allergen that was present in
             the participant's environment. A skin test was considered positive if the wheal
             produced by the allergen was equal to or greater than that caused by positive control
             (histamine) or was at least 3 mm (prick test) or 7 mm (intradermal test) greater than
             the wheal of negative control (saline). If a skin test could not be performed, the
             radioallergosorbent test (RAST) would be used as an alternative. Documented historical
             skin testing or RAST performed during the past year were acceptable

          4. Height within the 3rd and 97th percentiles at screening (Visit 1), Visit 2, and at
             randomization (Visit 3)

          5. Symptomatic (daily AM instantaneous total nasal symptom score was >= 4 out of 12) on
             any 4 out of the last 7 consecutive days immediately prior to and including the
             morning of Visit 3. Symptom ratings were to be completed with the help of a
             parent/guardian/caregiver

          6. Written informed consent and ability of parent or legal guardian of the participant to
             give a written informed consent before any study related procedures. Participants 7
             years of age and older must have provided a signed assent form

          7. Participants had to be toilet-trained

        Exclusion criteria:

          1. Gross nasal anatomical deformities including large polyposis and marked deviated
             septum

          2. History of or current cataract or glaucoma

          3. History of hypersensitivity to the corticosteroids or to any excipient of the
             investigational product

          4. Participant was the investigator or any sub-investigator, research assistant,
             pharmacist, study coordinator, other staff or relative thereof directly involved in
             the conduct of the protocol

          5. Height, weight, or body mass index (BMI)-for-age below the 3rd or above the 97th
             percentile at Visits 1, 2, or 3

          6. Treatment with systemic corticosteroids (oral, intravenous, intramuscular, or
             intra-articular) within 3 months prior to Visit 1

          7. 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.

          8. Treatment with inhaled, intranasal, or high potency topical corticosteroid exposure
             within 6 weeks prior to Visit 1. Mild asthma that was well-controlled and without the
             use of inhaled corticosteroids within 6 weeks before screening (Visit 1).

          9. Immunotherapy, except stable (>=1 month) maintenance schedule before Visit 1.

         10. Treatment with any substance before Visit 1 that might have affected growth velocity
             and/or linear growth, such as, but not be limited to methylphenidate hydrochloride,
             thyroid hormone, growth hormone, anabolic steroids, calcitonin, estrogens, progestins,
             bisphosphonates, anticonvulsants, or phosphate-binding antacids

         11. Treatment with any investigational product or device in the 30 days before Visit 1 or
             at any time throughout the duration of this trial (Visit 1 through Visit 11).

         12. Bone age as assessed by X-ray of the left hand and wrist that was outside +/- 1.5
             years of participants chronological age at Visit 2. Right hand and wrist were to be
             radiographed in the event of bone injury to the left hand or wrist.

         13. Unresolved upper respiratory tract infection, sinus infection or nasal candidiasis
             (i.e., symptomatic or under treatment) within the last 2 weeks before Visit 3.

         14. Participants or parent/guardian/caregiver unable to demonstrate correct administration
             of the investigational product at Visit 1.

         15. Concomitant disease other than PAR which could have interfered with the study
             procedures or outcomes as determined by the investigator.

         16. History of hospitalization due to asthma within 1 year before screening (Visit 1).

         17. Abnormal 24-hour urinary free cortisol level assessed at screening (Visit 2).

        The above information was not intended to contain all considerations relevant to potential
        participation in a clinical trial.