EUCTR2010-022279-77-DE进行中（未招募）不适用
A Phase II Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study to determine the efficacy and dose response of repeat inhaled doses of GW870086X on FEV1 in adults with Persistent 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
- 132
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 or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- •2. A female subject is eligible to participate if she is of non-childbearing potential.
- •3. Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 90-95 hours post-last dose.
- •4. Body weight, men > 50 kg, women > 45 kg and BMI within the range 18.5 – 29.0 kg/m2 (inclusive).
- •5. Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta-2 agonist therapy by inhalation or non ICS controllers or intermittent low dose ICS (maximum daily dose of 0.25mg FP or equivalent).
- •6. Severity of Disease: A best FEV1 of 60%-85% of the predicted normal value during the Visit 1 screening period.
- •7. No history of smoking within 6 months of the start of the study, and with a total pack year history of <10 pack years
- •8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •9. Single QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- •10. AST and ALT < 2xULN; alkaline phosphatase and bilirubin < 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •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. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- •2. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- •3. The subject has a positive pre-study drug/alcohol screen unless a positive can be explained by the patients’ medication.
- •4. Past or present disease, which as judged by the investigator, may affect the outcome of this study.
- •5. Clinically significant abnormalities in safety laboratory analysis at screening, as determined by the investigator.
- •6. Subject is hypertensive at screening.
- •7. History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.
- •8. Administration of oral, injectable or dermal steroids within 8 weeks of screening.
- •9. Exacerbation of asthma within 4 weeks prior to the first dose of study medication.
- •10. Respiratory Infection.
- •11. Asthma Exacerbation.
- •12. A positive test for HIV antibody.
- •13. History of regular alcohol consumption within 6 months of the study.
- •14. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- •15. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- •16. The subject is not able to understand or comply with protocol requirements, instructions and protocol stated restrictions.
- •17. Vulnerable subjects (e.g. subjects who are kept due to regulatory or juridical order in an institution).
- •18. Subject is mentally or legally incapacitated.
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