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)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- Growth Velocity
研究概览
简要总结
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
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Placebo (Other)
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.
干预措施: Claritin® (Drug)
TAA-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.
干预措施: Placebo (Other)
TAA-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.
干预措施: TAA-AQ, Nasacort® AQ (Drug)
TAA-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.
干预措施: Claritin® (Drug)
结局指标
主要结局
Growth Velocity
时间窗: 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.
次要结局
- 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))
- 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))
- 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 as Assessed by the Investigator During and at the End of the Double-blind Treatment Period(Day 120, Day 240 and Day 360)
- 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))
- 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))
- 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))
- 24 Hour Cortisol/Creatinine Ratio(Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420))
- Number of Participants With Treatment-emergent Adverse Events (TEAE)(From Day 1 to 7 days following end of treatment (Day 360))