EUCTR2012-001871-35-CZ进行中（未招募）不适用
AC4116136: A multicenter, randomized, double-blind, parallelgroupstudy to evaluate the efficacy and safety of the addition of umeclidinium bromide Inhalation Powder (62.5mcg) once-daily to fluticasone propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide Inhalation Powder (125mcg) once-daily to fluticasone propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticasone propionate/salmeterol (250/50mcg) twice-daily over 12 weeks in subjects with COPD.
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
- 600
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: 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 OR
- •Child bearing potential agreeing to one of the following contraceptive methods:
- •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.
- •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)]. Former 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-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a pre and post-albuterol/salbutamol FEV1 of =70% of predicted normal values at Visit 1 (Screening) calculated using Nutrition Health and Examination Survey
- •(NHANES) III reference equations.
- •8. Dyspnea: A score of =2 on the mMRC Dyspnea Scale at Visit 1.
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
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 conditions in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension,
- •sarcoidosis, or interstitial lung disease.
- •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: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) lactose/milk protein or magnesium stearate, or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholingeric.
- •6. Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
- •7. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1.
- •8. 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 study protocol. The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 4 of the study protocol.
- •9. Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 our period required prior to spirometry testing at each study visit.
- •10. Medications Prior to Screening: Use of the following medications according to the following defined time intervals prior to Visit 1:
- •*Please see table listed within study protocol, p20.
- •11. 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 exclusionary.
- •12. Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy.
- •13. Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
- •14. Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2
研究者
相似试验
进行中（未招募）
1 期
PL104884: A multicenter, randomized, double-blind, placebocontrolled, parallel-group, dose-ranging study of SB-480848, an oral lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, in subjects with stable coronary heart disease (CHD) or CHD-risk equivalent to examine chronic inhibition of Lp-PLA2, effects on circulating biomarkers associated with cardiovascular risk, safety and tolerability over 12 weeksSB-480848 is under developement as a potential anti-atherosclerosis agent for reduction of major cardiovascular events in high risk patient populations.EUCTR2005-003590-24-HUGlaxoSmithKline Research & Development Limited
进行中（未招募）
不适用
PL104884: A multicenter, randomized, double-blind, placebocontrolled, parallel-group, dose-ranging study of SB-480848, an oral lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, in subjects with stable coronary heart disease (CHD) or CHD-risk equivalent to examine chronic inhibition of Lp-PLA2, effects on circulating biomarkers associated with cardiovascular risk, safety and tolerability over 12 weeksSB-480848 is under developement as a potential anti-atherosclerosis agent for reduction of major cardiovascular events in high risk patient populations.EUCTR2005-003590-24-EEGlaxoSmithKline Research & Development Limited920
进行中（未招募）
1 期
PL104884: A multicenter, randomized, double-blind, placebocontrolled, parallel-group, dose-ranging study of SB-480848, an oral lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, in subjects with stable coronary heart disease (CHD) or CHD-risk equivalent to examine chronic inhibition of Lp-PLA2, effects on circulating biomarkers associated with cardiovascular risk, safety and tolerability over 12 weeksEUCTR2005-003590-24-GBGlaxoSmithKline Research & Development Limited
进行中（未招募）
不适用
PL104884: A multicenter, randomized, double-blind, placebocontrolled, parallel-group, dose-ranging study of SB-480848, an oral lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, in subjects with stable coronary heart disease (CHD) or CHD-risk equivalent to examine chronic inhibition of Lp-PLA2, effects on circulating biomarkers associated with cardiovascular risk, safety and tolerability over 12 weeksSB-480848 is under developement as a potential anti-atherosclerosis agent for reduction of major cardiovascular events in high risk patient populations.EUCTR2005-003590-24-DKGlaxoSmithKline Research & Development Limited920
进行中（未招募）
不适用
PL104884: A multicenter, randomized, double-blind, placebocontrolled, parallel-group, dose-ranging study of SB-480848, an oral lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, in subjects with stable coronary heart disease (CHD) or CHD-risk equivalent to examine chronic inhibition of Lp-PLA2, effects on circulating biomarkers associated with cardiovascular risk, safety and tolerability over 12 weeksSB-480848 is under developement as a potential anti-atherosclerosis agent for reduction of major cardiovascular events in high risk patient populations.EUCTR2005-003590-24-DEGlaxoSmithKline Research & Development Limited920