EUCTR2010-024435-16-DE进行中（未招募）不适用
A 12-week study to evaluate the effect of fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler (NDPI) on arterial stiffness compared with Tiotropium bromide 18 mcg delivered once daily via a HandiHaler in subjects with Chronic Obstructive Pulmonary Disease (COPD)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 248
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. Type of subject: Outpatient
- •2. Informed consent: Subjects must give their signed and dated written informed
- •consent to participate.
- •3. Gender: Male or female subjects
- •A female is eligible to enter and participate in the study if she is of:
- •Non-child bearing potential (i.e., physiologically incapable of becoming pregnant,
- •including any female who is post-menopausal or surgically sterile). Surgically sterile
- •females are defined as those with a documented hysterectomy and/or bilateral
- •oophorectomy or tubal ligation. Post-menopausal females are defined as being
- •amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age
- •appropriate, history of vasomotor symptoms. However in questionable cases, a blood
- •sample with FSH > 40MIU/ml and estradiol <40pg/ml (<140 pmol/L) is confirmatory.
- •Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study – screening to follow-up contact):
- •Complete abstinence from intercourse from screening until the Follow-Up Phone
- •Contact; or
- •Male partner is sterile (vasectomy with documentation of azoospermia) prior to
- •female subject entry into the study, and this male partner is the sole partner for that
- •subject; or
- •Implants of levonorgestrel inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or
- •Injectable progestogen administered for at least 1 month prior to study medication
- •administration and administered until the Follow-Up Phone Contact; or
- •Oral contraceptive (combined or progestogen only) administered for at least one
- •monthly cycle prior to study medication administration; or
- •Double barrier method: condom and occlusive cap (diaphragm or cervical/vault
- •caps) with spermicidal agent (foam/gel/film/cream/suppository); or
- •An intrauterine device (IUD), inserted by a qualified physician, with published data
- •showing that the highest expected failure rate is less than 1% per year; or
- •Estrogenic vaginal ring; or
- •Percutaneous contraceptive patches
- •4. Age: =40 years of age at Screening (Visit 1)
- •5. COPD diagnosis: Subjects with a clinical history of COPD in accordance with the
- •following definition by the American Thoracic Society (ATS) /European Respiratory
- •Society(ERS) [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.
- •6. Tobacco use: Subjects with a current or prior history of =10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
- •Note: Pipe and/or cigar use cannot be used to calculate pack-year history.
- •Number of pack years = (number of cigarettes per day/20) x number of years
- •7. Severity of Disease:
- •Subjects with a measured post-albuterol/salbutamol FEV1 <70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999;
- •Hankinson, 201
排除标准
- •1Pregnancy:Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- •2Asthma:Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
- •3Other respiratory disorders:The investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. View protocol for further information.
- •4A cardiovascular event:(e.g., Acute Coronary Syndrome, Stroke, Coronary Artery Bypass Surgery, Percutaneous Coronary Intervention) in the 6 months prior to Visit 1.
- •5Lung resection:Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1) or having had lung transplantation.
- •6Poorly controlled COPD:Subjects with poorly controlled COPD, defined as the occurrence of ‘acute worsening of COPD that is managed by subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician in the 6 weeks prior to Visit 1 or ‘subjects who are hospitalized due to poorly controlled COPD within 12 weeks of Visit 1’
- •7Lower respiratory tract infection:Subjects with lower respiratory tract
- •infection that required the use of antibiotics within 6 weeks prior to Visit 1.
- •8Other diseases/abnormalities:Subjects with historical or current evidence of clinically significant cardiovascular, gastrointestinal, neurological, psychiatric, renal, hepatic, immunological, endocrine view protocol for further nformation.
- •9Current severe heart failure (New York Heart Association class IV). Subject will be excluded if they have a known ejection fraction of <30%.
- •10Hypertension: In the judgment of the investigator the subject does not have uncontrolled hypertension meaning that they are unlikely to require medication adjustments during the study period.
- •11Abnormal and clinically significant 12-lead ECG:Investigators will be
- •provided with ECG reviews conducted by a local cardiologist to
- •assist in evaluation of subject eligibility. For this study, an abnormal and
- •clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: view protocol for further information.
- •The investigator will determine the medical significance of ECG abnormalities that are not exclusionary a priori at randomisation and determine if the subject is precluded from entering the study.
- •12Cancer:Subjects with carcinoma that has not been in complete remission for at least 5 years, view protocol for further information.
- •13Drug/food allergy:Subjects with a history of hypersensitivity to any of the study medications and or milk allergies view protocol.
- •14Drug/alcohol abuse:Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
- •15Subjects who are medically unable to withhold their albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit. For those subjects on a stable dose of Ipratropium bromide prior to V1, subjects who are medically unable to withhold their Ipratropium bromide for the 4-hour period required prior to spirometry testing at V1 and V2 (Ipratropium will not be allowed after V2).
- •16Additional medication:view Table 1.
- •17Initiation, discontinuation and/or changing dose of medications reported to affect a PWV: Subjects who have started, discontinued and/or are receiving the following med
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