Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)

Completed · Phase 4 · Has a placebo group

Conditions studied: Rhinitis, Allergic, Perennial

In brief

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

Key facts

Study ID

NCT00449072

Run by

Sanofi

People needed

299

Starts

2007-03-01

Expected to finish

2011-10-01

Last updated by the study team

2012-08-10

Who can join

Age: 3 and older, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• At least a one year history of PAR as assessed and documented by the investigator (with or without seasonal allergic rhinitis [SAR])
• 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
• Height within the 3rd and 97th percentiles at screening (Visit 1), Visit 2, and at randomization (Visit 3)
• 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
• 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
• Participants had to be toilet-trained

You may not qualify if…

• Gross nasal anatomical deformities including large polyposis and marked deviated septum
• History of or current cataract or glaucoma
• History of hypersensitivity to the corticosteroids or to any excipient of the investigational product
• 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
• Height, weight, or body mass index (BMI)-for-age below the 3rd or above the 97th percentile at Visits 1, 2, or 3
• 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 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).
• Immunotherapy, except stable (>=1 month) maintenance schedule before Visit 1.
• 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
• 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).
• 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.
• Unresolved upper respiratory tract infection, sinus infection or nasal candidiasis (i.e., symptomatic or under treatment) within the last 2 weeks before Visit 3.
• Participants or parent/guardian/caregiver unable to demonstrate correct administration of the investigational product at Visit 1.
• Concomitant disease other than PAR which could have interfered with the study procedures or outcomes as determined by the investigator.
• History of hospitalization due to asthma within 1 year before screening (Visit 1).
• 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.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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