A Randomized, Double-Blind, Double-Dummy, Parallel Group 12-Week Comparison of the Efficacy and Safety of Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a Metered-Dose-Inhaler 230/42mcg Twice-daily With Fluticasone Propionate/Salmeterol DISKUS 250/50mcg Twice-daily in Subjects With COPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the FSC HFA MDI in subjects with COPD. The dose of FSC HFA MDI to be evaluated corresponds to the dose of FSC DISKUS (250/50mcg twice-daily) that is indicated for the treatment of COPD associated with chronic bronchitis in the US. This study will last up to approximately 15 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests and will record their peak expiratory flow measurements daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The FSC HFA MDI used in this study has been approved by FDA for use in asthma while the FSC 250/50mcg DISKUS has been approved for use in asthma and COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •A current diagnosis of asthma.
- •Any clinically significant and uncontrolled disease, including but not limited to the following: neurological, psychiatric, renal, immunological, endocrine/metabolic (including uncontrolled diabetes, hypokalemia or thyroid disease), cardiovascular, neuromuscular, hepatic, gastric, or hematological abnormalities, or peripheral vascular disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would affect the efficacy analysis if the disease/condition exacerbated during the study.
- •A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis), including subjects with a diagnosis of alpha-1-antitrypsin deficiency. Allergic rhinitis is not exclusionary.
- •An abnormal and clinically significant chest x-ray or computed tomography (CT) scan not believed to be due to the presence of COPD. A chest x-ray must be taken if the subject has not had one within 6 months of Visit
- •An abnormal and clinically significant 12-lead electrocardiogram (ECG). For the purposes of this study, an abnormal ECG is defined as a 12-lead tracing which is interpreted with (but not limited to) any of the following:
- •Myocardial ischemia
- •Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome)
- •Clinically significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia) The study investigator will determine the clinical significance of any ECG abnormality and determine if a subject is precluded from entering the study.
- •Previously diagnosed cancer unless it is in complete clinical remission (no evidence of any tumor burden) at Visit
- •Localized carcinomas of the skin that have been resected for cure are not considered exclusionary.
- •Any immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or intranasal, inhaled, or oral corticosteroid including any components of the formulations (e.g. lactose or milk protein).
- •Initiation of systemic beta-blocker medications within 30 days of Visit
- •Use of products containing the protease inhibitor ritonavir (Norvir, Kaletra).
- •Use of the following medications within the defined times prior to Visit 1:
- •Medication (Exclusion Prior to Visit 1) Short-acting beta-agonists (e.g., albuterol) (6 hours) Ipratropium (6 hours) Ipratropium/albuterol combination product (6 hours) Oral beta-agonists (48 hours) Salmeterol and formoterol (48 hours) Theophylline preparations (48 hours) Tiotropium (48 hours) Long-acting beta-agonist/inhaled corticosteroid combination products (e.g., ADVAIR™ or Symbicort) (30 days) Inhaled corticosteroids (30 days) Oral or parenteral corticosteroids (30 days) Any investigational drug (30 days)
- •Lung resection surgery (e.g., lung volume reduction surgery, or lobectomy) within 1 year of Visit
- •A COPD exacerbation and/or infection of the upper or lower respiratory tract requiring treatment with systemic (oral or parenteral) corticosteroids and/or antibiotics that has not resolved within 30 days of Visit 1
- •A COPD exacerbation that resulted in hospitalization that has not resolved within 3 months of Visit
- •Use of nocturnal positive pressure [e.g., continuous positive airway pressure or bi-level positive airway pressure].
- •A body mass index (BMI) of ≥ 40kg/m².
- •Subject is a study investigator, sub-investigator, study coordinator, or employee of a participating investigator or immediate family members of the aforementioned.
- •Any intellectual deficiency including illiteracy, history of substance abuse in the two years prior to Visit 1 (including drug and alcohol), or other conditions, which will limit the validity of informed consent to participate in the study.
- •Supplemental oxygen, with the following exceptions:
- •Use at high altitude (> 5000 feet) provided subject does not require a flow rate of > 2 L/minute
- •Use for exertion provided subject does not require > 2 hours per day of oxygen and does not require a flow rate of > 2L/minute
- •Use for nocturnal therapy provided subject does not require a flow rate of > 2L/minute
研究组 & 干预措施
arm 2
干预措施: Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg (Drug)
arm 1
干预措施: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg (Drug)
结局指标
主要结局
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug
时间窗: 2 hours after administration of blinded study drug; Baseline through Week 12
The primary efficacy analysis was mean change from baseline in 2-hour post-dose FEV1 compared between the two treatment groups at Endpoint. Change from baseline was calculated as the value at Endpoint minus the baseline value. FEV1, which is assessed using spirometry, is the maximal amount of air you can forcefully exhale in one second. Endpoint was defined as the last scheduled observation for 2 hour post-dose FEV1 during the 12-week treatment period.
次要结局
- Mean Change From Baseline in AM Pre-dose FEV1(Measurement of FEV1 prior to study drug administration; Baseline through Week 12)
- Mean Change From Baseline in Peak Expiratory Flow(Baseline through Week 12)