EUCTR2005-004419-31-GB进行中（未招募）1 期
A multi-centre, randomised, double-blind, placebo-controlled, four-way incomplete block crossover study, to examine efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat administration of three inhaled doses (25, 100 and 400 µg once daily) of GW642444.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases (e.g. chronic bronchitis, emphysema, bronchiectasis , cystic fibrosis or bronchopulmonary dysplasia).
- •2. Male subjects or female subjects of non child bearing potential (i.e. post-menopausal or surgically sterile) aged between 18 to 70 years.
- •Post-menopausal females are defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However if indicated this should be confirmed by estradiol and FSH levels consistent with menopause (according to laboratory ranges) at screening.
- •Pre-menopausal females with a documented (medical report verification) hysterectomy and/or bilateral oophorectomy or Tubal Ligation.
- •3. Subjects who are current non-smokers, who have not used any inhaled tobacco products (snuff is permitted) in the 12 month period preceding the screening visit and who have a pack history of equal or less than 10 pack years.
- •Pack years = Number of cigarettes per day/20 x Number of years smoked
- •4. Subjects with clinically stable persistent asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 between 60 and 90% predicted (having abstained from bronchodilators for the required period). Predicted values are based on the ECCS 1993 normal ranges.
- •5. During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of equal or greater than 12.0% over baseline and an absolute change of equal or greater than 300 mL within 30 minutes following a single 400 mcg salbutamol dose.
- •6. Subjects who are able and willing to give written informed consent to take part in the study.
- •7. Subjects who are currently taking ICS 200-500 µg FP range
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1. Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, which may affect the safety of the subject or outcome of this study. The list of additional excluded conditions/diseases includes, but is not limited to the following:
- •congestive heart failure, known aortic aneurysm, clinically significant coronary heart disease, clinically significant cardiac arrhythmia, stroke within 3 months of the screening visit, uncontrolled hypertension (a), poorly controlled peptic ulcer, haematologic, hepatic, or renal disease, immunologic compromise, current malignancy (b), tuberculosis (current or quiescent), Cushing's disease
- •Addison's disease, uncontrolled diabetes mellitus, recent history of drug or alcohol abuse.
- •(a) systolic blood pressure >170, or diastolic blood pressure >100
- •(b) history of malignancy is acceptable only if subject has been in remission for one year prior to the screening visit (remission = no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to the screening visit)
- •2. A screening Holter ECG tracing that reveals clinically concerning arrhythmias (including, but not limited to, ventricular ectopic runs of equal or greater than 4 beats, R on T phenomena, bigeminy, trigeminy. A more stringent criteria is detailed in the SRM).
- •3. A mean QTc(B) value at screening >430 msec (male) / >450 msec (female) or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).
- •4. Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit
- •5. Subjects with a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with either respiratory arrest or hypoxic seizures.
- •6. Asthma exacerbations requiring treatment with oral corticosteroids: any exacerbations within 3 months of the screening visit or two or more exacerbations within 6 months of The screening visit or admittance to hospital for an asthma exacerbation within 1 year of the screening visit.
- •7. Subjects who have taken high doses of inhaled (> 500 mcg FP/day or equivalent) or oral steroids within 8 weeks of the screening visit.
- •8. Subjects who have changed their inhaled corticosteroid treatment within the last 4 weeks before screening or can be expected to do so during the study.
- •9. Subjects who have received a new chemical entity drug, or have received a marketed compound in a clinical study, within 3 months of the screening visit.
- •10. Any adverse reaction including immediate or delayed hypersensitivity to any ß2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GW642444 inhalation powder (i.e. lactose).
- •11. Subjects with a positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody or HIV (if tested according to site SOPs) result within 3 months of the start of the study.
- •12. Neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject’s proper completion of the protocol requirements, inclu
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