Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol (320 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (12 Years of Age and Older)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 474
- 试验地点
- 1
- 主要终点
- Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period
研究概览
简要总结
The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent
- •Documented history of perennial allergic rhinitis
- •A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.
- •Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12)
- •Other criteria apply
排除标准
- •History of physical findings of nasal pathology (within 60 days prior to screening visit)
- •Participation in any investigational drug study 30 days preceding screening visit
- •History of respiratory infection/disorder with 14 days preceding screening visit or during the run-in period
- •Use of any prohibited concomitant medications
研究组 & 干预措施
BDP HFA 320 µg/day
During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
干预措施: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol (Drug)
Placebo
During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
干预措施: Placebo Nasal Aerosol (Drug)
结局指标
主要结局
Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period
时间窗: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \& PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
次要结局
- Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period(Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period))
- Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(Baseline and Week 6)