Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Registration Number
- NCT00449072
- Lead Sponsor
- Sanofi
- Brief 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
- Detailed Description
The study consisted of:
* a 4- to 6-month screening/baseline period
* a 12-month (up to Day 360+/-5 days) double-blind treatment period starting on Day 1
* a 2-month follow-up period (up to Day 420+/-5 days)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 299
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Claritin® 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered * Placebo in the baseline/screening period to demonstrate administration of investigational product (IP) with the nasal spray bottle * Placebo in the double-blind treatment period All participants were provided Children's Claritin® Syrup as a rescue medication. TAA-AQ Claritin® 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered * Placebo in the baseline/screening period to demonstrate administration of IP with the nasal spray bottle * Triamcinolone acetonide (TAA-AQ) in the double-blind treatment period All participants were provided Children's Claritin® Syrup as a rescue medication. Placebo Placebo 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered * Placebo in the baseline/screening period to demonstrate administration of investigational product (IP) with the nasal spray bottle * Placebo in the double-blind treatment period All participants were provided Children's Claritin® Syrup as a rescue medication. TAA-AQ Placebo 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered * Placebo in the baseline/screening period to demonstrate administration of IP with the nasal spray bottle * Triamcinolone acetonide (TAA-AQ) in the double-blind treatment period All participants were provided Children's Claritin® Syrup as a rescue medication. TAA-AQ TAA-AQ, Nasacort® AQ 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered * Placebo in the baseline/screening period to demonstrate administration of IP with the nasal spray bottle * Triamcinolone acetonide (TAA-AQ) in the double-blind treatment period All participants were provided Children's Claritin® Syrup as a rescue medication.
- Primary Outcome Measures
Name Time Method Growth Velocity Day 1 to end of treatment (Day 360) Individual participant's growth velocity over double-blind treatment period was calculated using a linear regression of height over time.
Height was measured on the same wall-mounted Harpenden stadiometer with the participant barefoot and in light clothing.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Instantaneous Total Nasal Symptom Score (TNSS) For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment) PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:
* 0 = symptom absent
* 1 = mild (present but not annoying to self)
* 2 = moderate (annoying to self but not interfering with sleep or daily living)
* 3 = severe (interfered with daily living and/or sleep)
TNSS was the sum of the individual symptom scores (ranging 0-3), and TNSS ranged from 0 (best outcome) to 12 (worst outcome). A negative value for change represents an improvement in symptoms.Change From Baseline in Four Individual Nasal Symptom Scores at the End of Treatment For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment) PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:
* 0 = symptom absent
* 1 = mild (present but not annoying to self)
* 2 = moderate (annoying to self but not interfering with sleep or daily living)
* 3 = severe (interfered with daily living and/or sleep)
Individual symptom scores ranged from 0 (best outcome) to 3 (worst outcome). A negative value for change represents an improvement in symptoms.Global Efficacy as Assessed by the Participant (With the Help of a Parent/Guardian/Caregiver) During and at the End of the Double-blind Treatment Period Day 120, Day 240 and Day 360 Global efficacy was assessed by the participant (with the help of a parent/guardian/caregiver) using the following scale:
* 0 = no relief (symptoms unchanged or worse than before)
* 1 = slight relief (symptoms were present and only minimally improved)
* 2 = moderate relief (symptoms were present and could have been troublesome but were noticeably improved)
* 3 = marked relief (symptoms were greatly improved and although present were scarcely troublesome)
* 4 = complete relief (virtually no symptom present)Global Efficacy as Assessed by the Investigator During and at the End of the Double-blind Treatment Period Day 120, Day 240 and Day 360 Global efficacy was assessed by the investigator using the following scale:
* 0 = no relief (symptoms unchanged or worse than before)
* 1 = slight relief (symptoms were present and only minimally improved)
* 2 = moderate relief (symptoms were present and could have been troublesome but were noticeably improved)
* 3 = marked relief (symptoms were greatly improved and although present were scarcely troublesome)
* 4 = complete relief (virtually no symptom present)Percentage of Participants Who Used the Rescue Medication During the Double-blind Phase of the Study Baseline (4-6 months before Day 1), double-blind treatment period (Day 1 to Day 360) and follow-up (Day 361 to Day 420) Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary.
The percentage of participants who used the rescue medication during each of the study periods is reported.Percentage of Days Participants Used the Rescue Medication During the Double-blind Treatment Phase of the Study double-blind treatment period (Day 1 to Day 360) Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary.
The percentage of days that participants used the rescue medication during the double-blind treatment phase of the study.24 Hour Urinary Free Cortisol Levels Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420) Urine cortisol levels was determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be \[1.4 - 21 μg/24 hours\].
24 Hour Cortisol/Creatinine Ratio Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420) Urine cortisol and creatinine levels were determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be \[1.4 - 21 μg/24 hours\]. No normal range is available for cortisol/creatinine ratio.
Number of Participants With Treatment-emergent Adverse Events (TEAE) From Day 1 to 7 days following end of treatment (Day 360) Adverse events that developed, worsened, or became serious during the double-blind treatment period or within 7 days after the last dose of double-blind investigational product (IP) are defined as TEAEs.
A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:
* Resulted in death
* Was life-threatening
* Required inpatient hospitalization or prolongation of existing hospitalization
* Resulted in persistent or significant disability/incapacity
* Was a congenital anomaly/birth defect
* Was a medically important event
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇺🇸Bridgewater, New Jersey, United States