A randomized, multi-center, double-blind, doubledummy, parallel group study to evaluate the efficacy and safety of umeclidinium bromide/vilanterol compared with fluticasone propionate/salmeterol over 12 weeks in subjects with COPD - Not Applicable

GlaxoSmithKline Research & Development Ltd0 个研究点目标入组 710 人2013年1月28日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: GlaxoSmithKline Research & Development Ltd
入组人数: 710
状态: 进行中（未招募）
最后更新: 12年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2013年1月28日

结束日期

待定

最后更新

12年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

GlaxoSmithKline Research & Development Ltd

入排标准

入选标准

•1\. Type of subject: Outpatient
•2\. Informed Consent: A signed and dated written informed consent prior to study participation
•3\. Age: Subjects 40 years of age or older at Visit 1
•4\. 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, \> 45 years, in the absence of hormone replacement therapy. OR 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):
•Abstinence
•Oral Contraceptive, either combined or progestogen alone
•Injectable progestogen

排除标准

•1\. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
•2\. Asthma: A current diagnosis of asthma
•3\. Other Respiratory Disorders: Known a\-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject, who, in the opinion of the investigator, has any other significant respiratory condition in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. Inactive tuberculosis in more than one lobe is exclusionary. Allergic rhinitis is not exclusionary.
•4\. Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for \<5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through
•participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
•5\. Contraindications: A history of allergy or hypersensitivity to any
•anticholinergic/muscarinic receptor antagonist, beta2\-agonist, corticosteroid, lactose/milk protein or magnesium stearate or a medical condition such as narrowangle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of a inhaled anticholinergic.
•6\. Hospitalization: Hospitalization for pneumonia within 12 weeks prior to Visit 1
•7\. History of COPD Exacerbation: A documented history of at least one COPD exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics, and/or hospitalization. Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence.
•8\. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1\)