EUCTR2012-000927-42-GB进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-Controlled, Cross-Over, Single-Centre Study to Investigate the Acute Lung Deflation Effects of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg Once Daily on Cardiac Biventricular Function and Arterial Stiffness in Adults with Chronic Obstructive Pulmonary Disease (COPD)
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 96 人开始时间: 2012年9月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
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
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •1. Type of subject: Outpatient.
- •2. Informed consent: Subjects must give their signed and dated written informed consent to participate.
- •3. Gender: Males or females. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
- •4. Age 40 and above
- •5. Smoking history of at least 15 pack years. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
- •6. Established diagnosis of COPD according to ATS/ERS criteria.
- •Subjects with a measured post-albuterol/salbutamol FEV1 <70% of predicted normal values
- •FEV1/FVC ratio after bronchodilator < 0.7
- •Post-bronchodilator spirometry will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of salbutamol via an MDI with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated.
- •MRC SCORE > 1
- •7. Residual Volume (RVol) =20% above predicted value demonstrating evidence of reversibility post bronchodilator of =7.5% predicted.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
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 they also have a current diagnosis of COPD).
- •3. a1-antitrypsin deficiency: Subjects with known a-1 antitrypsin deficiency as the underlying cause of COPD
- •4. Other respiratory disorders: Subjects with active tuberculosis or lung cancer as well as clinically significant bronchiectasis, sarcoidosis, pulmonary fibrosis, interstitial lung diseases or other active pulmonary diseases. Pulmonary hypertension from causes other than COPD.
- •5. Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant or pneumonectomy.
- •6. A moderate/severe COPD exacerbation that has not resolved at least 14 days prior to screening and at least 30 days following the last dose of oral corticosteroids (if applicable).
- •7. Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to screening.
- •8. Pulmonary Rehabilitation: Patients to be excluded if they have been in the acute phase of pulmonary rehabilitation in the 4 weeks prior to screening
- •9. Current severe heart failure. Subjects will also be excluded if they have a known ejection fraction of <30%.
- •10. Abnormal and clinically significant 12-lead ECG
- •11. Other systemic inflammatory conditions associated with chronic inflammation in the opinion of the investigator (e.g. rheumatoid arthritis, connective tissue disorders and Inflammatory Bowel Disease)
- •12. Other significant diseases / abnormalities: Any life-threatening condition with life expectancy <1 year, other than vascular disease or COPD, that might prevent the subject from completing the study.
- •13. Coronary Artery Bypass Grafting (CABG) in the 6 months prior to screening.
- •14. Myocardial infarction, cerebrovascular event or coronary artery intervention other than CABG in the 1 month prior to screening. Inclusion of these patients with events over 1 month prior to screening will be based on physician’s judgment.
- •15. History of malignancy within the past 5 years, other than non-melanoma skin cancer.
- •16. End stage chronic renal disease: Subjects will be excluded if on renal replacement therapy (hemodialysis or peritoneal).
- •17. 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). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject’s participation will also be excluded.
- •18. Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
- •19. Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen should not be initiated during the
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