NCT01092403已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Three-Way Crossover Study to Evaluate the Safety, Tolerability and Clinical Activity of ASM-024 Administered by Inhalation Once Daily to Subjects With Mild Allergic 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
- 24
- 试验地点
- 3
- 主要终点
- Late asthmatic response (LAR)
研究概览
简要总结
The study will assess the safety, tolerability and clinical activity of ASM-024 in subjects with mild allergic 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 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 ≤ 50 years of age;
- •Female subjects of childbearing potential must have a negative pregnancy test (serum b-HCG) at Pre-Screening, and a negative urine pregnancy test immediately before the first administration of the study drug for each of the three Treatment Periods. Sexually active females 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 a IUD. Male subjects must ensure that their female partner is willing to use adequate contraception;
- •Diagnosis of mild allergic asthma that meets the following criteria:
- •Stable on inhaled short-acting beta-2-agonists p.r.n. as the only medication for asthma.
- •Presence of both early asthmatic response (EAR) (at least 20 % fall in FEV1 within 3 hours after allergen inhalation) and late asthmatic response (LAR) (at least 15 % fall in FEV1).
- •Baseline methacholine (PC20) ≤ 16 mg/mL.
- •FEV1 of at least 70 % of the predicted value at Pre-Screening and Screening / Baseline;
- •BMI ≥ 19 and ≤ 35 kg/m²;
- •Body weight ≥ 40 kg;
- •Positive skin prick test to at least one common aeroallergen.
排除标准
- •Any lung disease other than mild allergic asthma;
- •Pregnant or nursing women or women intending to conceive during the course of the study or have a positive serum pregnancy test at Pre-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. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e., less than 1 % per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence or a partner who has undergone a vasectomy;
- •Respiratory tract infections or worsening of asthma within 6 weeks before Screening/Baseline;
- •Baseline methacholine PC20 > 16 mg/mL at Screening / Baseline;
- •Current cigarette smokers or former smokers with a smoking history of greater than 10 pack years or who stopped smoking within the 12 months preceding enrolment in the study;
- •Use of any nicotine containing products within 6 months before Pre-Screening;
- •Any of the following concomitant medications:
- •Any medication that are known to prolong QT / QTc interval.
- •Oral or inhaled corticosteroids within 28 days preceding Pre-Screening or systemic corticosteroids within 90 days of Pre-Screening.
- •Long acting beta-2-agonists within one week preceding Baseline.
- •Use of inhaled short-acting β2- agonists or anticholinergics within 8 hours before all study visits to the clinic.
- •Known or suspected allergy or sensitivity to nicotine or cholinergic drugs or any drug with similar chemical structure;
- •Clinically significant ECG abnormalities at Pre-Screening including clinically significant or marked baseline prolongation of QT / QTc interval (e.g. repeated demonstration of a QTc interval of > 450 ms). Other non clinically significant findings such as sinus bradycardia, sinus arrhythmia, borderline first degree AV block (up to 205 ms), left ventricular hypertrophy (on voltage criteria for a subject less than 40 years old for instance) are permissible if judged to be acceptable by the Qualified investigator;
- •Family history of additional risk factors for TdP (e.g., family history of Long QT Syndrome.
研究组 & 干预措施
ASM-024
Experimental
ASM-024 once daily by inhalation
干预措施: ASM-024 (Drug)
Placebo
Placebo Comparator
Placebo once daily by inhalation
干预措施: Placebo (Drug)
结局指标
主要结局
Late asthmatic response (LAR)
时间窗: Day 8 of each treatment period
LAR as measured by the peak drop in FEV1 from 3 to 7 hours post-allergen challenge
Early asthmatic response (EAR)
时间窗: Day 8 of every treatment period
EAR as measured by the peak drop in FEV1 from 0 to 3 hours post-allergen challenge
Airway hyperresponsiveness
时间窗: Days -1, 7 and 9 of each treatment period
Difference between methacholine PC20 measured 24 hours following allergen challenge and methacholine PC20 measured 24 hours before allergen challenge
Safety and tolerability
时间窗: Physical examination: Day 9, vital signs: Days -1, 1, 7, 8 and 9; twelve-lead ECG: Days 1, 7, 8 and 9 , AEs throughout the study, safety laboratory assessments Day 1 and 9 and Chest X-Ray: Day 9 of the final treatment period
次要结局
- LAR's FEV1 AUC(Day 8 of every treatment period)
- FEV1(Day 9)
- EAR's FEV1 AUC(Day 8)
- Change in FEV1(Days 1, 7, 8 and 9)
- Induced sputum eosinophil count and eosinophil and neutrophil percentages(Days -1, 7 and 9 of every Treatment Period)
- Blood eosinophil count(Days -1 and 9 of every Treatment Period)
- Total and differential WBC count(Days -1 and 9 of every Treatment Period)
研究者
研究点 (3)
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