NCT01689571已完成2 期
A Randomised, Double-blind, Placebo-controlled, Three-way Crossover Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Two Doses of Inhaled CHF6001 DPI After 9 Days of Treatment in Adult Patients With Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Allergen challenge
研究概览
简要总结
The study is designed to look at the safety, tolerability and efficacy of 2 different doses of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once a day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF 6001 after an allergen challenge.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent obtained
- •Non smoking or ex-smokers from at least 1 year prior to study entry
- •Males of females between 18 and 60 years inclusive
- •Body Mass Index between 18 and 32 kg/m2
- •Ability to be trained about the proper use of the inhalation device and to perform spirometry
- •With mild to moderate allergic asthma as defined by the GINA guideline, steroid naive
- •Atopy to at least one common aeroallergen
- •Positive allergen-induced Early Asthmatic Response and Late Asthmatic Response at screening
- •Ability to produce an adequate sputum sample
- •Post-menopausal women, women of not childbearing potential or males and females of childbearing potential willing (they or their partner) to use a reliable method of contraception.
排除标准
- •Worsening of asthma or respiratory tract infection prior to study entry
- •History of life-threatening asthma or hospitalization for asthma prior to the study entry
- •Pregnant or lactating women
- •History of clinically significant hypotensive episodes or fainting, dizziness or light-headedness
- •History or symptoms of clinically relevant neurologic disease
- •Symptomatic hay fever
- •Unstable concurrent disease that may impact the feasibility of the study
- •Use of systemic corticosteroids, nebulised bronchodilator or oral beta2-agonist
- •Use of leukotrienes modifiers, roflumilast or cromoglycate
- •Use of long acting beta2-agonist or inhaled corticosteroids
- •Use of short-acting or long-acting non-sedatives antihistamines
- •Use of any other medication for the treatment of allergic asthma other than salbutamol
- •Having received an investigational medicinal drug within 30 days prior to study entry
- •Blood drawn of at least 250 ml in the previous 45 days
- •Ongoing use of tobacco
- •Other lung disease
- •Recent history of alcohol dependency
- •Inability to comply with the study protocol
研究组 & 干预措施
Placebo DPI
Placebo Comparator
Placebo by inhalation for 9 days
干预措施: Placebo (Drug)
CHF6001 DPI Dose 2
Experimental
CHF6001 by inhalation for 9 days
干预措施: CHF6001 (Drug)
CHF6001 DPI Dose1
Experimental
CHF6001 by inhalation for 9 days
干预措施: CHF6001 (Drug)
结局指标
主要结局
Allergen challenge
时间窗: after 9 days of treatment
次要结局
- Induced Sputum(After 9 days of treatment)
- Methacholine challenge(After 9 days of treatment)
研究者
研究点 (3)
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