A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP HFA Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis When Administered in Adolescent and Adult Subjects (12 to 45 Years of Age) With Perennial Allergic Rhinitis (PAR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment
研究概览
简要总结
The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent
- •Male or female subjects 12-45 years of age
- •Documented history of perennial allergic rhinitis
- •General good health
- •Other criteria apply
排除标准
- •History of physical findings of nasal pathology (within 60 days prior to Screening Visit 1)
- •Participation in any investigational drug study 30 days preceding Screening Visit 1
- •History of respiratory infection/disorder with 14 days preceding Screening Visit 1
- •Use of any prohibited concomitant medications
研究组 & 干预措施
Placebo
Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
干预措施: Placebo Nasal Aerosol (Drug)
Placebo
Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
干预措施: Placebo Prednisone Capsules (Drug)
BDP HFA 320 µg/day
Participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
干预措施: Placebo Prednisone Capsules (Drug)
BDP HFA 320 µg/day
Participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
干预措施: Beclomethasone dipropionate (Drug)
Prednisone
Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
干预措施: Placebo Nasal Aerosol (Drug)
Prednisone
Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
干预措施: Prednisone capsules (Drug)
结局指标
主要结局
The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment
时间窗: Day 0 (Baseline), Day 42
Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an "other pre-specified" outcome.
次要结局
未报告次要终点