A 6-Month Open-Label, Long-Term Safety Extension Study of Once Daily Ciclesonide HFA Nasal Aerosol (160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 824
- 试验地点
- 42
- 主要终点
- Percentage of Subjects Experiencing Adverse Events (AEs)
研究概览
简要总结
6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147). Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily in patients with Perennial Allergic Rhinitis.
详细描述
This is a 6-month multi-center, open-label, long-term safety extension study in subjects who have completed Study 060-633 (NCT00953147). This study is designed to evaluate the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject has successfully completed all visits of Study 060-
- •Subject has given written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- •Subject is male or female 12 years and older.
- •Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, clinical laboratory tests, and medical history.
- •Subject, if female 65 years of age or younger, must have a negative urine pregnancy test (performed at Visit 1). Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
- •An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
- •Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
- •Abstinence.
排除标准
- •Female subject who is pregnant or lactating.
- •History of physical findings of nasal pathology, including nasal polyps.
- •Subject has any condition that, in the judgment of the investigator, would preclude the subject from completing the study.
研究组 & 干预措施
ciclesonide
ciclesonide HFA 160 μg once daily
干预措施: ciclesonide HFA 160 μg (Drug)
结局指标
主要结局
Percentage of Subjects Experiencing Adverse Events (AEs)
时间窗: Weeks 1-26
Percentage of Subjects Experiencing Serious Adverse Events (SAEs)
时间窗: Weeks 1-26
Percentage of Subjects Who Discontinue Due to AEs.
时间窗: Weeks 1-26
次要结局
- Percentage of Subjects Experiencing Local Nasal AEs(Weeks 1-26)
- Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.(Baseline and Weeks 1-26)
- Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.(Baseline and Weeks 1-26)
- Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.(Baseline and Months 1, 2, 3, 4, 5, and 6)
- Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.(Baseline and Months 1, 2, 3, 4, 5, 6)
- Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances(Weeks 0-12)
- Number of Devices With Actuation Consistency(Weeks 0-6 and 6-12)
- Percentage of Devices With Actuation Consistency(Weeks 0-6 and 6-12)
- Number of Devices With Major Discrepancies(Weeks 0-6 and 6-12)
- Percentage of Devices With Major Discrepancies(Weeks 0-6 and 6-12)
- Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey(Weeks 6 and 12)