NCT01437540已完成3 期
A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 590
- 试验地点
- 137
- 主要终点
- Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
- •A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.
排除标准
- •Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
- •Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit
- •Patients with any clinically significant respiratory conditions other than COPD
- •Clinical history that suggests that the patient has asthma as opposed to COPD
- •Chronic use of oxygen therapy ≥ 15 hours/day
- •Patients with clinically significant cardiovascular conditions
- •Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
- •Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
- •Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
- •Current diagnosis of cancer other than basal or squamous cell skin cancer
研究组 & 干预措施
1
Experimental
Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day
干预措施: Aclidinium Bromide/Formoterol Fumarate (Drug)
2
Active Comparator
Inhaled formoterol fumarate 12 μg, twice per day
干预措施: Formoterol Fumarate (Drug)
结局指标
主要结局
Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)
时间窗: Up to study Week 56 ± 3 days
TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)
次要结局
- Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure(Up to study Week 56 ± 3 days)
- Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline(Up to study Week 56 ± 3 days)
- Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study(Up to study Week 52)
研究者
研究点 (137)
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