EUCTR2008-000727-26-SE进行中（未招募）不适用
Study HZC111348, a repeat-dose study of GW685698/GW642444 Inhalation Powder versus placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •1. Informed consent: Subjects must give their signed written informed consent to participate.
- •2. Gender: Male subjects or female subjects of non-child bearing potential (e.g. post-menopausal or surgical sterile) 40 - 80 years of age at screening (Visit 1).
- •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 can be confirmed by estradiol and FSH levels consistent with menopause (according to laboratory ranges) at screening (Visit 1).
- •Surgically sterile females are defined as those with a documented (medical report verification) hysterectomy and/or bilateral oophorectomy or Tubal Ligation.
- •Furthermore, male subjects in this study must use double-barrier (condom/spermicide) birth control methods or abstain from sexual intercourse with female partners who are pregnant, lactating, or able to bear children in addition to any birth control methods the female partner is using, from the first dose of the study medication until 90 days after the last dose of the study medication.
- •3. COPD diagnosis: 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 characterized 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.
- •4. Tobacco use: subjects with a current or previous history of =/>10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
- •Number of pack years = (number of cigarette per day/20)) x number of years smoked
- •5. Severity of Disease: subjects who conform to the current severity classification for Stage II/III disease in terms of post-bronchodilator spirometry at Screening Visit 1:
- •Subject with a measured post-salbutamol FEV1/FVC ratio of =/< 0.70
- •Subjects with a measured post-salbutamol FEV1 =/> 40 % and =/< 80 % of predicted normal values calculated using NHANES III reference equations.
- •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
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1. Pregnancy: Women who are pregnant or lactating
- •2. Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if COPD is the current diagnosis)
- •3. Alpha 1- antitrypsin deficiency: Subjects with Alpha-1 antitrypsin deficiency as the underlying cause of COPD
- •4. Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
- •5. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening
- •6. Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Screening if a chest X-ray or CT scan is not available within 6 months prior to Screening
- •7. Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of any of the following in the 2 months prior to Screening:
- •Acute worsening of COPD that requires medication (e.g. oral corticosteroid, antibiotics) prescribed by a physician, or
- •Acute worsening of COPD for which the subject is hospitalized.
- •8. Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1
- •9. 12-lead ECG (Electrocardiogram): An abnormal and clinically significant 12-lead ECG result. For this study, an abnormal ECG is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following:
- •Clinically significant conduction abnormalities (e.g. left bundle branch block, Wolff-Parkinson-White syndrome)
- •Clinically significant arrhythmias (e.g. atrial fibrillation, ventricular tachycardia)
- •The investigator will determine the clinical significance of any ECG abnormalities and determine if a subject is precluded from entering the study. However, the following predetermined ECG abnormalities are considered clinically significant and will result in exclusion of a subject: Please view protocol for further information.
- •10. Other Diseases/abnormalities: Please view protocol for further information.
- •11. Hepatitis: Subjects with a positive Hepatitis B surface antigen or positive Hepatitis C antibody pre-study or at Screening
- •12. Hypertension: Uncontrolled hypertension, defined as a supine blood pressure equal to or higher than 150/95 mmHg at Screening in subjects NOT receiving medication for hypertension; or
- •Uncontrolled hypertension, defined as a supine blood pressure equal to or higher than 140/95 mmHg at Screening in subjects receiving medication for hypertension (refer to ‘prohibited medications’)
- •13. Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Please view protocol for further information.
- •14. Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). Please view protocol for further information.
- •15. Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
- •16. Medication prior to spirometry: Subjects who are medically unable to withhold their rescue medication for the 6-hour period require
研究者
相似试验
已完成
2 期
A Study To Assess Single Dosage Strength Of GW685698/GW642444 Chronic Obstructive Pulmonary Disease (COPD)Pulmonary Disease, Chronic ObstructiveNCT00731822GlaxoSmithKline60
进行中（未招募）
不适用
HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) - NDPatients with Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: SOCClassification code 10038738EUCTR2009-013063-19-ITGlaxoSmithKline Research & Development1,560
进行中（未招募）
不适用
HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of fluticasone furoate/GW642444 inhalation powder with GW642444m on the annual rate of exacerbations in subjects with chronic obstructive pulmonary diseaseEUCTR2009-013063-19-EEGlaxoSmithKline Research & Development1,560
进行中（未招募）
不适用
Study AZ3110866, a fixed dose study of SB-742457 versus placebo when added to existing donepezil treatment in subjects with mild-to-moderate Alzheimer's diseaseAlzheimer's diseaseMedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseEUCTR2008-000827-25-DEGlaxoSmithKline Research & Development Ltd672
进行中（未招募）
不适用
Study AZ3110866, a fixed dose study of SB-742457 versus placebo when added to existing donepezil treatment in subjects with mild-to-moderate Alzheimer's disease - NDSubjects with mild-to-moderate probable Alzheimer's diseaseMedDRA version: 9.1Level: LLTClassification code 10012271Term: Dementia Alzheimer's typeEUCTR2008-000827-25-ITGlaxoSmithKline Research & Development Ltd672