Official Title: “A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study of the 12 Month Effect of Treatment With Once Daily Triamcinolone Acetonide (NASACORT® AQ Nasal Spray 110 μg) on the Growth Velocity of Children, 3 to 9 Years of Age, With Perennial Allergic Rhinitis (PAR)”

The primary objective of the study is to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with PAR treated with TAA nasal spray (NASACORT AQ 110 μg treatment group) or placebo (NASACORT AQ placebo group) for 12-months.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2010

Intervention(s) in this Clinical Trial

• Drug: triamcinolone acetonide
  • triamcinolone acetonide (TAA) AQ 110 μg (one 55-μg actuation/nostril) administered intranasally qd in subjects 3 to 9 years of age
• Other: placebo
  • TAA AQ placebo (one actuation/nostril) administered intranasally qd in subjects 3 to 9 years of age

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • triamcinolone acetonide (TAA) AQ 110 μg (one 55-μg actuation/nostril) administered intranasally qd in subjects 3 to 9 years of age
• Placebo Comparator: 2
  • TAA AQ placebo (one actuation/nostril) administered intranasally qd in subjects 3 to 9 years of age

Primary Measures

• To characterize the difference in prepubescent growth velocity during the 12-month treatment period in children 3 to 9 years of age with PAR treated with triamcinolone acetonide (TAA) nasal spray (Nasacort AQ 110 μg) or placebo (Nasacort AQ placebo)
  • Time Frame: This study will consist of a 4-month (120+5 days) baseline period, a 12-month (365+5 days) baseline period, and a 2-month (60+5 days) follow-up period.
    Safety Issue?: Yes

Secondary Measures

• To compare 24 hr urinary free cortisol levels and the cortisol/creatinine ratio in prepubertal subjects treated with TAA nasal spray vs placebo.
  • Time Frame: This study will consist of a 4-month (120+5 days) baseline period, a 12-month (365+5 days) baseline period, and a 2-month (60+5 days) follow-up period.
    Safety Issue?: Yes
• To assess the global efficacy of TAA nasal spray vs placebo as rated separately by the investigator and the subject (with the help of a parent/guardian/caregiver) during and at the end of the double-blind treatment period.
  • Time Frame: This study will consist of a 4-month (120 ± 5 days) baseline period (of which 2 weeks are single-blind), a 12-month (365 ± 5 days) treatment period, and a 2-month (60 ± 5 days) follow-up period.
    Safety Issue?: No
• To determine the rate of use of rescue medication with TAA nasal spray vs placebo during each phase of the study (baseline, double-blind & follow up)
  • Time Frame: This study will consist of a 4-month (120 ± 5 days) baseline period (of which 2 weeks are single-blind), a 12-month (365 ± 5 days) treatment period, and a 2-month (60 ± 5 days) follow-up period.
    Safety Issue?: No

Inclusion criteria:

• 1. Male subjects [3 years to ≤9 years + 0 days old] at Visit 1 and no older than [9 years
• + 120 days] at Visit 3; and, female subjects [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 maturity1) at Visit 1 and Visit 3. A 5-day extension to the age upper bound would be 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 is present in the subject's environment. A skin test is considered positive if the wheal produced by the allergen is equal to or greater than that caused by positive control (histamine) or is at least 3 mm (prick test) or 7 mm (intradermal test) greater than the wheal of negative control (saline). If a skin test cannot be performed, the radioallergosorbent test (RAST) will be used as an alternative. Documented historical skin testing or RAST performed during the past year will be acceptable
• 4. Height within the 3rd and 97th percentiles2 at screening (Visit 1), Visit 2, and at randomization (Visit 3)
• 5. Symptomatic (daily AM instantaneous total nasal symptom score is ≥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 will be completed with the help of a parent/guardian/caregiver
• 6. Written informed consent and ability of parent or legal guardian of the subject to give a written informed consent before any study related procedures. Subjects 7 years of age and older must provide a signed assent form
• 7. Subjects must 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. Subject is the investigator or any subinvestigator, 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-age2 below the 3rd or above the 97th percentile2 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 corticosteroid courses for >2 courses, each course not exceeding 14 days, within 1 year before Visit 1.
• 8. Treatment with inhaled, intranasal, or high potency topical corticosteroid exposure within 6 weeks prior to Visit 1. Mild asthma will be 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 may affect 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. Unresolved upper respiratory tract infection, sinus infection or nasal candidiasis (i.e., symptomatic or under treatment)within the last 2 weeks before Visit 3.
• 13. Subjects or parent/guardian/caregiver unable to demonstrate correct administration of the investigational product at Visit 1.
• 14. Concomitant disease other than PAR which could interfere with the study procedures or outcomes.
• 15. History of hospitalization due to asthma within 1 year before screening (Visit 1).
• 16. Abnormal 24-hour urinary free cortisol level assessed at screening (Visit 2).
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 9 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Tara Semanchek, MBA Study Director Sanofi-Aventis  

Overall Contact: Public Registry USMA  PublicRegistryUSMA@sanofi-aventis.com

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00449072

Study ID Number: XRG5029C/3503

ClinicalTrials.gov Identifier: NCT00449072

Health Authority: United States: Food and Drug Administration