NCT02266927已完成1 期
An Open-Label, 2-Part, Randomized, Crossover Study to Compare the Bioavailability of Intranasal Administration of 200 and 400 µg of OPTINOSE™ FLUTICASONE With 400 µg of Flonase® (Fluticasone Propionate) Nasal Spray (Part 1), and Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE™ FLUTICASONE With 440 µg of Flovent® HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2) (Current Investigation is Part 2 Only)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The ratio of least-squares means of the ln transformed PK parameter AUC0-∞ is the primary endpoint.
研究概览
简要总结
To compare the systemic exposure of a single dose of 400 µg of OPTINOSE FLUTICASONE with 440 µg of Flovent® HFA (fluticasone propionate) Inhalation Aerosol in asthmatic subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects' ages 18 to 55 years, inclusive, at screening.
- •Have a body mass index of 18 to 32 kg/m2, inclusive, and a body weight of not less than 52 kg for males and 45 kg for females.
- •Otherwise healthy mild to moderate asthmatic (Part 2) with no clinically relevant abnormalities in the opinion of the Investigator as determined by medical history, physical examination, blood chemistry, hematology (including complete blood count), serology, urinalysis, vital signs, and ECG performed at screening.
- •History of mild to moderate asthma, diagnosed by a physician, which is well controlled at the present time (no history of sudden or severe asthma exacerbation in the past 12 months).
- •Are unlikely to exacerbate during the study due to seasonal allergen exposure.
- •Able to tolerate withdrawal of their medication for a required period of time.
排除标准
- •Currently have or have a history of disease or dysfunction of the cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, musculoskeletal, or other body system that is clinically significant in the opinion of the Investigator.
- •History of smoking or use of nicotine-containing substances within the previous 3 months before screening.
- •Hypersensitivity to fluticasone propionate or any of the excipients found in OPTINOSETM FLUTICASONE or Flovent® HFA (for Part 2).
- •History of extensive nasal and/or sinus surgery.
- •Known nasal obstruction including allergic rhinitis, nasal septal deviations, polyposis, severe mucosal swelling, nasal ulcers, nasal trauma or any other reason.
- •History of acute severe asthma attacks.
- •History of seasonal asthma exacerbation, in which case subjects should be outside the relevant allergen season.
- •Have evidence of any chronic medical conditions other than asthma requiring prescription medications (e.g., hypertension or diabetes).
- •Have used inhaled, intranasal, oral, or injectable corticosteroids within 4 weeks prior to dosing. Subjects should be on stable treatment for at least 1 month prior to withdrawal.
研究组 & 干预措施
Flovent® HFA 440µg
Active Comparator
Flovent® HFA (fluticasone propionate) Inhalation Aerosol 440 µg
干预措施: Flovent HFA (Drug)
OPTINOSE™ FLUTICASONE 400µg intranasal
Experimental
OPTINOSE™ FLUTICASONE, single dose of 400 µg intranasally
干预措施: OPTINOSE™ FLUTICASONE (Drug)
结局指标
主要结局
The ratio of least-squares means of the ln transformed PK parameter AUC0-∞ is the primary endpoint.
时间窗: Pre-dose and at 0.167, 0.333, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 9, 12, 16, 24, and 36 hours after dosing
Part 2
次要结局
未报告次要终点
研究者
研究点 (1)
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