NCT01908140已完成3 期
A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With 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
- 933
- 试验地点
- 1
- 主要终点
- Peak Forced Expiratory Volume in One Second (FEV1) at Week 24
研究概览
简要总结
The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with 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
- Triple (Participant, 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
- •Adult male or non-pregnant, non-lactating female aged ≥
- •Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years
- •Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a post-bronchodilator FEV1 <80%, and FEV1/FVC < 70% at Screening Visits
- •Symptomatic patients with a COPD assessment test (CAT) ≥10 at Screening and Randomisation Visits
- •Patient must be able to perform repeatable pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria at Screening Visits
- •Patients eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained
排除标准
- •History or current diagnosis of asthma
- •Development of a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit or during the run-in period
- •Clinically significant respiratory conditions
- •Type I or uncontrolled Type II diabetes, uncontrolled hypo- or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
- •Patients who, in the investigator's opinion, may need to start a pulmonary rehabilitation programme during the study and/or patients who started/finished it within 3 months prior to Screening Visit
- •Use of long-term oxygen therapy (≥15 hours/day)
- •Patients treated on daily basis with triple therapy (LABA+LAMA+ICS) within 4 weeks prior to the Screening Visit
- •Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers
- •Clinically significant cardiovascular conditions
- •Patient with clinically relevant abnormalities in the results of the clinical laboratory tests, ECG parameters or in the physical examination at the Screening Visit
- •Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
- •Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
- •Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis
- •History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer
- •Patient with any other serious or uncontrolled physical or mental dysfunction
- •Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment
- •Patient unlikely to be cooperative or that can't comply with the study procedures
- •Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Screening Visit
- •Patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication
- •Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study
研究组 & 干预措施
Aclidinium Bromide / Formoterol Fumarate
Experimental
Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
干预措施: Aclidinium Bromide / Formoterol Fumarate (Drug)
Salmeterol / Fluticasone propionate
Active Comparator
Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
干预措施: Salmeterol / Fluticasone (Drug)
结局指标
主要结局
Peak Forced Expiratory Volume in One Second (FEV1) at Week 24
时间窗: At Week 24
Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration
次要结局
- Transition Dyspnoea Index (TDI) Focal Score at Week 24(At Week 24)
研究者
研究点 (1)
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