EUCTR2008-001209-41-NL进行中（未招募）不适用
A multi-center, double-blind, placebo-controlled, randomized, multiple dose, 2-period cross-over, Phase IIa study to investigate the pharmacodynamics, tolerability and safety, and pharmacokinetics of ACT 129968 in subjects with mild to moderate allergic asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men and women not of childbearing potential 18–55 years of age (inclusive).
- •-Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile.
- •Signed informed consent prior to any study-mandated procedure.
- •Having stable, mild to moderate allergic asthma for at least 1 year and fulfilling all of the following criteria at screening (all assessments should be performed within a period of 1 week):
- •–No ongoing or recent treatment (see definition below) for allergic airway disease (prescribed or over-the-counter [OTC]) other than stable use of short-acting, inhaled beta2 agonist as needed.
- •–Asymptomatic hay fever at screening, which is expected to remain asymptomatic during the study.
- •–No hospital admissions for asthma in the previous year.
- •–FEV1 >= 70% of predicted value at both of the screening visits, measured >= 8h after any use of a short-acting inhaled beta2 agonist.
- •–Airway hyperresponsiveness to inhaled methacholine (Mch) with the provocative concentration of Mch causing a fall in baseline FEV1 of 20% (PC20FEV1) (Mch) < 16 mg/mL Mch chloride.
- •–Early and late allergic reaction (EAR, LAR) airway response with >= 15% minimal reduction in FEV1 during LAR (3–10h) following a standardized bronchial allergen challenge with house dust mite (HDM) extract.
- •Positive skin prick test (wheal diameter >= 3 mm) to HDM extract within 1 year before screening.
- •Body mass index (BMI) between 18 and 33 kg/m2 (inclusive) at screening.
- •Systolic blood pressure (SBP): 100–150 mmHg, diastolic blood pressure (DBP): 50–90 mmHg and heart rate (HR): 40–90 bpm (all inclusive) after 5 minutes in the supine position at screening.
- •12-lead electrocardiogram (ECG) without clinically relevant abnormalities at screening.
- •Hematology, biochemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
- •Negative results from drug screen (amphetamines, cocaine, cannabinoids, opiates, benzodiazepines, cotinine) at screening.
- •Ability to communicate well with the investigator in the local language and to understand and comply with the requirements of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Ongoing or recent (see below) treatment with medications for allergic airway disease (either prescribed or OTC) other than short-acting, inhaled beta2 agonist.
- •Recent treatment for the following medications is defined as:
- •–Systemic corticosteroids: within 8 weeks prior to screening.
- •–Inhaled corticosteroids: within 4 weeks prior to screening.
- •–Intranasal corticosteroids: within 4 weeks prior to screening.
- •–Leukotriene receptor antagonists: within 2 weeks prior to screening.
- •–Cromoglycate: within 2 weeks prior to screening.
- •–Theophylline: within 1 week prior to screening.
- •–Anti-histamines: within 1 week prior to screening.
- •–Long-acting beta2 agonists: within 1 week prior to screening.
- •–Anti-cholinergics: within 1 week prior to screening.
- •–Anti-immunoglobulin E (IgE): within 6 months prior to screening.
- •–Immunotherapy: any previous use.
- •–Other medications: at the discretion of the investigator and with the sponsor’s consent.
- •Smoking within the last year or life-time consumption > 10 pack-years
- •Symptoms of a clinically relevant lower respiratory tract infection in the 3-week period prior to screening.
- •Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma.
- •Planned treatment or treatment with another investigational drug within 3 months prior to screening.
- •Loss of 250 mL or more of blood within 3 months before the screening examination.
- •Positive HIV serology.
- •History of hepatitis B or C and/or positive hepatitis serology, indicating acute or chronic hepatitis B or C.
- •History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to the screening examination.
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with treatment compliance, study conduct or interpretation, such as any unstable medical abnormality or a disease which could affect the absorption, distribution, metabolism, or excretion of the study drug.
- •Known hypersensitivity to any excipients of the study drug formulation.
- •Any clinically relevant drug or food allergy.
- •Legal incapacity or limited legal capacity at screening.
研究者
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