A Two-Part, Randomized, Placebo-Controlled, Crossover Trial to Evaluate the Differential Effects of Inhaled Nedocromil, Oral Montelukast, and Inhaled Mometasone on Markers of the Early Airway Response to Allergen in Asthmatics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Change in Plasma 9P at 20 Minutes
研究概览
简要总结
This study will assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone.
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
- Double (Participant, Investigator)
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
- •History of mild to moderate Asthma
- •In good general health (except for asthma)
- •Stable and free of respiratory infection
- •Nonsmoker
- •Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control)
排除标准
- •Nursing mother
- •Recent or ongoing upper or lower respiratory tract infection
- •Unable to refrain from or anticipates the use of any prescription and non-prescription drugs
- •Consumes excessive amounts of alcohol or caffeine
- •History of stroke, chronic seizures, or major neurological disorder
- •History of cancer
- •Received a vaccination within the past 3 weeks
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Nedocromil
Nedocromil
干预措施: Nedocromil (Drug)
结局指标
主要结局
Change in Plasma 9P at 20 Minutes
时间窗: Pre-allergen challenge and 20 minutes post allergen challenge
Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge
Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes
时间窗: Pre-allergen challenge and 5 minutes post allergen challenge
Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge
Change in Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Pre-allergen challenge and 20 minutes after allergen challenge
Maximal percent drop in FEV1 at 20 minutes post allergen challenge
次要结局
- Allergen-induced Concentrations of Sputum LTC4(2 hours post allergen challenge)
- Allergen-induced Concentrations of Sputum LTD4(2 hours post allergen challenge)
- Allergen-induced Changes in Urinary Leukotriene (LT) E4(Baseline and 2 hours post allergen challenge)
- Allergen-induced Concentrations of Sputum LTE4(2 hours post allergen challenge)
- Allergen-induced Changes in Urinary 9P(Baseline and 2 hours post allergen challenge)