NCT01190826已完成2 期
Single-Center, Randomized, Double-Blind, Placebo-Controlled, Three-Way Crossover Study to Evaluate the Safety, Tolerability and Clinical Activity of a Single Dose of ASM-024 Administered by Inhalation to Subjects With Stable Moderate 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
- 20
- 试验地点
- 3
- 主要终点
- Peak change in FEV1 following inhalation of ASM-024
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and clinical activity of ASM-024 in stable moderate 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Able and willing to provide written informed consent.
- •Male or female subjects, ≥ 18 years and ≤ 55 years of age
- •Diagnosis of moderate asthma and on regular inhaled corticosteroids with or without short or long-acting Beta-2-agonists
- •FEV1 ≥ 55 % predicted in the absence of medications for asthma
- •Female subjects of childbearing potential must have a negative pregnancy test (serum beta-human chorionic gonadotropin (b-HCG)) at Screening, and a negative pregnancy test immediately before the administration of the study drug for each of Periods 1, 2 and
- •Sexually active females with non-sterile partner must be willing to use adequate contraception.
- •Male subjects must be willing to use a condom with a spermicide for the duration of their participation in the study, plus an additional 30 days following study drug administration and ensure that their partner is using a highly effective method of birth control such as combined oral contraceptives, implants, injectables or an intra-uterine device (IUD). Male subjects must ensure that their female partner is willing to use adequate contraception.
- •Demonstration of an increase in FEV1 by ≥ 10 % predicted between spirometry performed before and 10-20 minutes after the administration of 2 puffs of 100 micrograms of salbutamol at Screening.
排除标准
- •Clinically significant conditions or illnesses other than moderate asthma or systemic diseases
- •Pregnant or nursing women or women intending to conceive during the course of the study or have a positive serum pregnancy test at Screening or a positive urine pregnancy test during the study.
- •Women of childbearing potential (unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years) not using a highly effective method of birth control.
- •Non-surgically sterile males and males with partners of childbearing potential not willing to use a condom with spermicide for the duration of their participation in the study plus an additional 30 days following study drug administration and to ensure that their partner is using a highly effective method of birth control such as combined oral contraceptives, implants, injectables or an IUD.
- •Respiratory tract infections or worsening of asthma or changes in asthma medications within 6 weeks before Screening/Baseline.
- •Current cigarette smokers or former smokers with a smoking history of greater than 10 pack years or who stopped smoking within 12 months preceding enrolment in the study.
- •Positive urine cotinine test at Screening.
- •History of illicit drug use or alcohol abuse within 12 months before Screening.
- •Positive test for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV) at Screening.
- •Any medication that are known to prolong QT / QTc interval.
- •Any of the following concomitant medications preceding the administration of salbutamol during Screening and preceding the administration of the study drug:
- •Oral or i.v. corticosteroids within 1 month;
- •Inhaled or intranasal corticosteroids within 48 hours;
- •Long acting Beta-2-agonists within 24 hours;
- •Short acting Beta-2-agonists within 8 hours;
- •Anticholinergic aerosols within 24 hours; and
- •Theophylline-containing products within 48 hours.
- •Use of NSAIDs within 7 days preceding the administration of salbutamol during Screening and throughout the study.
- •Use of antihistaminic drugs within 3 days preceding the administration of salbutamol during Screening.
- •Use of an investigational product or participation in a clinical trial using an investigational product within 30 days before dosing or within 90 days in the case of long-acting products (ex.: Depo-medrol) or biologics with a long-acting half-life (ex.: monoclonal antibodies).
研究组 & 干预措施
ASM-024 10 mg
Experimental
ASM-024 administered once by inhalation at a target dose of 10 mg
干预措施: ASM-024 (Drug)
ASM-024 100 mg
Experimental
ASM-024 administered once at a target dose of 100 mg
干预措施: ASM-024 100 mg (Drug)
Placebo
Placebo Comparator
Placebo administered once by inhalation
干预措施: Placebo (Drug)
结局指标
主要结局
Peak change in FEV1 following inhalation of ASM-024
时间窗: Over a period of 6 hours following administration
次要结局
- FEV1 AUC following inhalation of ASM-024(Over 6 hours following administration)
研究者
研究点 (3)
Loading locations...
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