EUCTR2008-005168-15-DE进行中（未招募）不适用
A randomized, double-blind, two way cross-over, proof of concept study to compare the efficacy, safety, pharmacokinetics and pharmacodynamics of two-week oral administration of QAV680 versus placebo, with an extended open-label inhaled corticosteroid period, in steroid-free, mild to moderate persistent asthma patients
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •1. Male and female patients aged 18 to 65 years with symptomatic mild to moderate persistent asthma for = 6 months
- •2. Patients should be steroid naive or off steroids and chromoglycate (by any route) for at least 4 weeks before randomisation. Only use of short-acting ß2-agonists is permissible as rescue medication.
- •3. Patients should have pre-bronchodilator FEV1 =60% predicted with =12% or 200 mL improvement post short acting ß2-agonist (200µg inhaled Salbutamol).
- •Patients who are NOT on ICS during screening need to demonstrate reversibility during screening visit
- •Patients who are on steroids need to demonstrate reversibility during the first baseline AFTER their steroid-withdrawal
- •4. Women must be postmenopausal or surgically sterilized at the time of participation as defined in the protocol.
- •5. Male subjects must be using a two acceptable methods of contraception as defined in the protocol up to the Study Completion visit and refrain from fathering a child in the 3 months following the last study drug administration.
- •6. Subjects must weigh at least 45 kg and have a body mass index (BMI) within the range of 20 to 30 kg/m2.
- •7. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
- •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
- •1. Smokers (defined as history of smoking in the previous 2 months)
- •2. Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing other than short acting inhaled beta-agonists and paracetamol is acceptable but must be documented in the Concomitant CRF.
- •3. Participation in any clinical investigation within 4 weeks prior to initial dosing.
- •4. Donation or loss of 400 ml or more of blood within 8) weeks prior to initial dosing. Hemoglobin levels below 12.0 g/dl at screening.
- •5. Significant illness within 2 weeks prior to initial dosing.
- •6. Patients with positive stool examination at screening for helminthic, ova or parasitic infections.
- •7. Past medical history of clinically significant ECG abnormalities, or recent history of hypertension or autonomic dysfunction
- •8. Recent history (within past three months) of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.
- •9. Use of theophylline or long acting ß2 agonists in the last 2 weeks prior to dosing
- •10. Pregnant or lactating women.
- •11. Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period.
- •12. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication. Patients with other serious underlying diseases as defined in protocol.
- •13. History of multiple allergies to drugs or allergy to the investigational compound/compound class being used in this study.
- •17. Vulnerable patients (e.g. patients kept in detention)
- •---REFER TO STUDY PROTOCOL FOR FULL LIST OF EXCLUSION CRITERIA---
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