NCT02273817已完成3 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Comparing the Bioquivalence of Ciclesonide Nasal Spray(Apotex Inc.) to That of Omnaris ™Nasal Spray (Sepracor, Inc.) in the Treatment of Seasonal Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Apotex Inc.
- 入组人数
- 580
- 主要终点
- Treatment Of Seasonal Allergic Rhinitis
研究概览
简要总结
This study is to evaluate the equivalence of generic ciclesonide nasal spray with that of the marketed drug, Omnaris™ nasal spray, in the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic ciclesonide nasal spray compared with Omnaris™ nasal spray.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If female of childbearing potential, is not pregnant (confirmed by negative urine pregnancy test) or lactating and must have used reliable birth control measures throughout the study.
- •At least a 2-year reliable medical history consistent with SAR
- •Positive skin test within 12 months of screening to at least one seasonal allergen present in the geographical area
- •Capable of tolerating intranasal application of the IMP, willing and able to comply with the requirements of the protocol
- •No clinically significant findings in physical and nasal examinations, and medical history.
- •A reflective TNSS of at least 6 (out of 12) in the 24 hours prior to placebo lead-in visit.
- •Successfully complete the placebo lead-in period.
排除标准
- •- Signs or symptoms of nasal polyps, deviated septum, or any other condition which, in the opinion of the Investigator, could resulted in erroneous study data.
- •Undergo nasal surgery or had nasal trauma within 3 months of screening.
- •Active respiratory conditions or respiratory tract infection that require antibiotic treatment within 2 weeks of screening
- •Persistent allergic rhinitis (PAR) that does not require or not expected to require active PAR treatment during the study period.
- •Evidence of any unstable or clinically significant conditions that would place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives.
- •Presence or history of clinically significant conditions which in the opinion of the Investigator would have compromised the safety of the subject or the conduct of the study.
- •Use of corticosteroids, intranasal cromolyn, Leukotriene inhibitors, long or short acting antihistamines, intranasal or systemic decongestants prior to the start of the single-blind, placebo lead-in visit within the time periods specified in the protocol or receiving immunotherapy.
- •Use of an investigational drug within 30 days before screening or during the study.
- •Known or suspected hypersensitivity to corticosteroids.
- •Inability to avoid exposure to chicken pox or measles.
- •Infection requiring oral antibiotic treatment 2 weeks prior to screening.
- •Previously identified as a placebo responder or known as a non responder to corticosteroids.
- •History of alcohol, drug, or substance abuse in the 12 months prior to Visit 1 (screening).
- •Positive for hepatitis B or C, or human immunodeficiency virus (HIV).
- •Uncooperative or non compliant.
- •Female subjects who planned to become pregnant during the conduct of the study.
- •Current smoker (former smokers had to be 6 months smoke free).
研究组 & 干预措施
Ciclesonide Nasal Spray (Apotex, Inc.)
Experimental
Ciclesonide nasal spray
- Dosage form: contain the aqueous medium of each metered-dose pump spray formulation unit plus the active ingredient, ciclesonide.
- Strength: 50 μg per actuation.
- Batch/Lot number (Expiry date): JM6697 (May 2012)
- Manufacturer: Apotex, Inc.
干预措施: Ciclesonide nasal spray, 50 μg per actuation. (Drug)
Omnaris™ nasal spray
Active Comparator
Omnaris™ Nasal Spray,
- Dosage form: contain the aqueous medium of each metered-dose pump spray formulation unit plus the active ingredient, ciclesonide
- Strength: 50 μg per actuation
- Batch/Lot number (Expiry date): 131657 (03/2012)
- Manufacturer: Sepracor, Inc.
干预措施: Ciclesonide nasal spray, 50 μg per actuation. (Drug)
Placebo
Placebo Comparator
Placebo
- Dosage form: Contain the aqueous medium of each metered-dose pump spray formulation unit minus the active ingredient, ciclesonide.
- Batch/Lot number (Expiry date): JR3808 (Nov 2012)
- Manufacturer: Apotex, Inc.
干预措施: Ciclesonide nasal spray, 50 μg per actuation. (Drug)
结局指标
主要结局
Treatment Of Seasonal Allergic Rhinitis
时间窗: 5 months
Change from baseline in the combined reflective Total nasal symptom score (TNSS) (combined AM and PM reflective scores of runny nose, nasal congestion, nasal itchiness, and sneezing).
次要结局
- Treatment Of Seasonal Allergic Rhinitis(5 months)
研究者
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