Safety of PATANASE® Nasal Spray in Patients With Perennial Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,260
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)
研究概览
简要总结
The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent;
- •Normal nasal exam;
- •History of perennial allergic rhinitis;
- •Allergy to perennial allergen documented by allergy testing;
- •Age 12 years and older;
- •Must follow instructions;
- •Must make required study visits;
- •Negative pregnancy test and adequate birth control methods for females of childbearing potential;
- •Refrain from certain allergy medications during the study;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Nasal disorders;
- •Use of substances that affect the nasal septum;
- •Exposure to industrial metal plating solutions;
- •Uncontrolled, severe, or unstable diseases;
- •Hypersensitivity to the study drug or nasal spray components;
- •Relative of site staff with access to the protocol;
- •Participation in another investigational study within 30 days or at the same time as this study;
- •Medical Monitor decision;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
PATANASE
Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months
干预措施: Olopatadine hydrochloride 0.6% nasal spray (PATANASE) (Drug)
Patanase Vehicle, pH 3.7
Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months
干预措施: Olopatadine nasal spray vehicle, pH 3.7 (Other)
Patanase Vehicle, pH 7.0
Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months
干预措施: Olopatadine nasal spray vehicle, pH 7.0 (Other)
结局指标
主要结局
Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)
时间窗: Baseline (Day 0), Exit (Month 12 or sooner)
Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.
Self-Rated Relief Assessment at Day 30
时间窗: Day 30
Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: "I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief."
次要结局
- Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)(Baseline (Day 0), Exit (Month 12 or sooner))
- Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)(Baseline (Day 0), Exit (Month 12 or sooner))
- Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)(Baseline (Day 0), Exit (Month 12 or sooner))
- Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)(Baseline (Day 0), Exit (Month 12 or sooner))