EUCTR2007-001391-37-DE进行中（未招募）不适用
A randomised, single-dose, dose ascending, double-blind, placebo controlled, four-way, incomplete block crossover study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled doses of GW642444M with magnesium stearate in COPD patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. Male subjects or female subjects of non child bearing potential (i.e. post-menopausal or surgically sterile) between 40 and 75 years of age at screening
- •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 oestradiol and FSH levels consistent with menopause (according to laboratory ranges) at screening.
- •Surgically sterile females are defined as those with a documented (medical report verification) hysterectomy and/or bilateral oophorectomy or tubal ligation.
- •2. Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]:
- •COPD is a preventable and treatable disease characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
- •3. Body weight equal or greater than 50 kg and BMI within the range 18 - 32 kg/m2.
- •4. Subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent). A former smoker is defined as a subject who has not smoked for equal or greater than 12 months at screening.
- •5. Subjects with a post-bronchodilator FEV1 to FVC ratio (FEV1/FVC) < 0.7 at screening visit.
- •6. Subjects with a post-bronchodilator FEV1 equal or greater than 40% and < 80% of predicted normal (according to ECCS guidelines) for height, age and gender at screening.
- •7. Subject is able and willing to give written informed consent to take part in the study.
- •8. Subject is available to complete all study measurements and procedures.
- •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
- •1. Subjects who have a past or present disease, which may affect the outcome of this study.
- •2. Women who are pregnant or lactating or of child bearing potential.
- •3. Subjects with a primary diagnosis of asthma. (Subjects with a prior history of asthma are eligible if COPD is currently their primary diagnosis).
- •4. Subjects with alpha-1 antitrypsin deficiency as the underlying cause of COPD.
- •5. Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease or other active pulmonary disease.
- •6. Subjects with lung volume reduction surgery within the 12 months prior to screening.
- •7. Subject has had an upper respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.
- •8. Subjects with hypoxaemia, or subjects receiving treatment with long-term oxygen therapy (LTOT). All subjects must have an Oxygen (O2) saturation of greater or equal than 88% on room air.
- •9. Subjects with a positive Hepatitis B surface antigen or positive hepatitis C antibody pre-study or at screening.
- •10. Subjects with poorly controlled COPD:
- •acute worsening of COPD that is managed by subject at home with oral corticosteroids or antibiotics in the 6 weeks prior to screening, or
- •more than two exacerbations in the previous 12 months prior to screening that required a course of oral corticosteroids or antibiotics, or, for which the subject was hospitalised.
- •11. Subjects with a blood potassium level <3.5 mmol/L at screening.
- •12. Subjects with clinically important cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
- •13. Uncontrolled hypertension defined as a mean supine blood pressure equal to or higher than 160/90 mmHg at screening in subjects not receiving medication for hypertension.
- •Uncontrolled hypertension defined as a mean supine blood pressure equal to or higher than 150/90 mmHg at screening in subjects receiving medication for hypertension (please refer to exclusion criteria for prohibited medications).
- •14. A mean heart rate outside the range 50 – 90 beats per minute (bpm) at screening.
- •15. Subjects with carcinoma that has not been in complete remission for at least 5 years.
- •16. Subjects with a history of hypersensitivity to any beta-agonist or to ipratropium bromide. In addition patients with a history of milk protein allergy will also be excluded.
- •17. Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
- •Abuse of alcohol is defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females)..
- •18. Subjects who are predicted to be medically unable to withhold their rescue medication for the 6 hour period required prior to spirometry testing at each study visit would be ineligible for the study.
- •19. The subjects must not have used the medications listed in Section 9.2 prior to screening for the required interval.
- •20. Subjects receiving treatment with tricyclic antidepressants, Monoamine Oxidase Inhibitors (MAOI), or beta-adrenergic antagonist would be ineligible for the study.
- •21. Subjects receiving treatment with long term or short-term oxygen therapy or who require nocturnal positive pressure
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