EUCTR2012-000525-45-GR进行中（未招募）不适用
DB2114930: A randomized, multi-center, double-blind, doubledummy, parallel group study to evaluate the efficacy and safety of umeclidinium/vilanterol compared with fluticasonepropionate/salmeterol over 12 weeks in subjects with COPD. - Advair v Zephyr
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
- 710
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. 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, ncluding 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
- •Implants of levonorgestrel
- •Estrogenic vaginal ring
- •Percutaneous contraceptive patches
- •Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP
- •effectiveness criteria as stated in the product label
- •Male partner sterilization (vasectomy with documentation of azoospermia) prior
- •to the female subject's entry into the study, and this male is the sole partner for
- •that subject. For this definition, documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records.
- •Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent
- •(foam/gel/film/cream/suppository)
- •5. Diagnosis: An established clinical history of COPD in accordance with the definition
- •by the American Thoracic Society/European Respiratory Society [Celli, 2004] as follows:
- •Chronic obstructive pulmonary disease is a preventable and treatable disease state
- •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. Smoking history: Current or former cigarette smokers with a history of cigarette
- •smoking of =10 pack-years [number of pack years = (number of cigarettes per
- •day/20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10
- •cigarettes per day for 20 years)]. Previous smokers are defined as those who have
- •stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot
- •be used to calculate pack year history.
- •7. Severity of disease: A pre and post-salbutamol FEV1/FVC ratio of <0.70 and a postsalbutamol FEV1 of =30% and =70% of predicted normal values calculated using
- •NHANES III reference equations at Visit 1 [Hankinson, 1999; Hankinson, 2010].
- •8. Dyspnea: A score of =2 on the Modified Medical Research Counc
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 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 an 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)
- •9. 12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by
- •a centralized independent cardiologist to assist in evaluation of subject eligibility.
- •Specific ECG findings that preclude subject eligibility are listed in Appendix 4 of the protocol.
- •(Section 11.4). The study investigator will determine the medical significance of any
- •ECG abnormalities not listed in Appendix 4.
- •10. Medication Prior to Spirometry: Unable to withhold salbutamol for the 4 hour
- •period required prior to spirometry testing at each study visit
- •11. Medications Prior to Screening: Use of the following medications according to the
- •following defined time intervals prior to Visit 1: (refer to protocol p.25).
- •12. Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., =12 hours per day) is not exclusi
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