NCT00989521已完成1 期
Double-blind, Placebo-controlled Crossover Evaluation of the Effect of PUR003 on Subjects With Asthma
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
- 7
- 试验地点
- 1
- 主要终点
- Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments.
研究概览
简要总结
PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma.
Study objectives are to :
- to evaluate the safety of PUR003 in subjects with asthma, and
- to evaluate the efficacy of PUR003 in assisting the treatment of asthma.
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
- •Signed written informed consent.
- •Ability and willingness to return to the outpatient clinic for repeated clinic visits and complete all assessments.
- •Adult male or female subject, 18-60 years of age.
- •Stable, mild asthma not requiring any medical treatment other than short acting inhaled bronchodilators, as needed.
- •No smoking within six months prior to entry
- •Must be medically stable.
- •Female subjects must have a negative pregnancy test
- •Subjects of child bearing potential should be sexually inactive (abstinent) for 14 days prior to the first dose of study medication or using an acceptable form of birth control methods.
排除标准
- •History or presence of significant co-existing chronic diseases.
- •History of asthma exacerbations or upper or lower respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) within four weeks of first visit.
- •Pregnancy, breastfeeding.
- •Abused alcohol or illicit drugs that required treatment.
- •Participated in any other investigational drug evaluation within last 30 days.
- •Scheduled to have elective or invasive medical intervention, procedure, or surgery within 6 months.
研究组 & 干预措施
placebo
Placebo Comparator
normal saline for inhalation
干预措施: Placebo (Drug)
PUR003
Active Comparator
PUR003 for inhalation
干预措施: PUR003 (Drug)
结局指标
主要结局
Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments.
时间窗: after three doses
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)AsthmaNCT00092144Organon and Co500
已完成
3 期
New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe AsthmaAsthmaNCT00393952SkyePharma AG557
已完成
3 期
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With AsthmaAsthmaNCT00393991SkyePharma AG475
已完成
3 期
Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)Asthma, BronchialRhinitis, Allergic, PerennialNCT00092105Organon and Co58
已完成
3 期
A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With AsthmaAsthmaNCT06502366AstraZeneca424