A Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Aclidinium Bromide 400 μg Bid on COPD Symptoms and Sleep Quality After 3 Weeks of Treatment in Patients With Stable Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
2016年9月20日 更新者:AstraZeneca
A Pilot, Double-blind, Placebo-controlled, 2-period Crossover Study to Assess the Effect of Aclidinium Bromide 400 μg Bid on COPD Symptoms and Sleep Quality After 3 Weeks of Treatment in Patients With Stable Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to assess the effect of aclidinium bromide compared with placebo in improving dilatation of the airways (bronchodilation), symptoms of chronic obstructive pulmonary disease (COPD), sleep quality and physical activity after 3 weeks of treatment with aclidinium bromide 400 μg administered twice daily in patients with stable moderate-and-severe COPD.
研究概览
研究类型
介入性
注册 (实际的)
30
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Grosshansdorf、德国、22927
- Pulmonary Research Institute at the Lung Clinic Grosshansdorf
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Immenhausen、德国、34376
- Pneumologische Lehrklinik der Universitätsmedizin Göttingen
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adult male or non-pregnant, non-lactating female aged ≥40 years. Women of childbearing potential will follow specific study requirements (negative serum pregnancy test at the Screening Visit and are using, over the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control
- Current or ex-cigarette smoker (patients who quit smoking more than 6 months prior to the Screening Visit), with a smoking history of at least 10 pack-years.
- Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) according to GOLD guidelines 2013, with a post bronchodilator FEV1 <80%, and FEV1 ≥ 40% at Screening Visit
- Patients must be able to perform repeatable pulmonary function testing for FEV1 according to American Thoracic Society [ATS]/European Respiratory Society [ERS] 2005 criteria at Screening Visit
- Patients who are eligible and able to participate in the study and who consents to do so in writing after the purpose and nature of the investigation have been explained
Exclusion Criteria:
- History or current diagnosis of asthma
- Patients with moderate to severe sleep apnoea assessed at screening
- Patients who develop a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit (Visit 1) or during the run-in period
- Clinically significant respiratory conditions
- Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
- Patients who may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to the Screening Visit
- Use of long-term oxygen therapy (15 hours/day)
- Patients who does not maintain regular day/night, waking/sleeping cycles including night shift workers
- Clinically significant cardiovascular conditions
- QTc >470 milliseconds in the manual ECG reading performed at Screening Visit
- Patients with clinically relevant abnormalities in the opinion of the investigator at the Screening Visit (Visit 1) in the results of the clinical laboratory tests, ECG parameters or in the physical examination)
- Patients with a history of hypersensitivity reaction to inhaled anticholinergics, long and short acting β2-agonists, sympathomimetic amines, or inhaled medication or any component there of (including report of paradoxical bronchospasm)
- Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
- Patients with known non-controlled history of human immunodeficiency virus (HIV) infection 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
- Patients with any other serious or uncontrolled physical or mental dysfunction, or moderate-to-severe depression, as confirmed by Beck Depression Inventory (BDI-II) total score >28.
- Patients with a history (within 2 years prior to the Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment
- Patients unlikely to be cooperative or that can't comply with the study procedures.
- Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to the Screening Visit
- Patients who intends 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Aclidinium bromide
Aclidinium bromide 400 μg administered via oral inhalation (Genuair® dry powder inhaler) one inhalation twice daily (12 hours apart, morning and evening).
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其他名称:
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安慰剂比较:Placebo
Placebo administered via oral inhalation (Genuair® dry powder inhaler) one inhalation twice daily (12 hours apart, morning and evening).
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-24hr
大体时间:0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11, 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment
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0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11, 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Change From Baseline in Morning Trough FEV1
大体时间:Week 3 of treatment
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Week 3 of treatment
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Change From Baseline in Peak FEV1
大体时间:Week 3 of treatment
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Week 3 of treatment
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Change From Baseline in Normalized FEV1 AUC0-12hr
大体时间:0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours at Week 3 of treatment
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0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours at Week 3 of treatment
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Change From Baseline in Normalized FEV1 AUC12-24hr
大体时间:12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment
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12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment
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Change From Baseline in the Average Rating of Overall Early Morning COPD Symptom Severity
大体时间:Week 3 of treatment
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Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI].
Scores ranged from 0 (no symptoms) to 4 (very severe symptoms).
The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]).
Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms
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Week 3 of treatment
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Change From Baseline in the Average Rating of Overall Evening COPD Symptom Severity
大体时间:Week 3 of treatment
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The evening symptoms questionnaire was filled out after the second medication administration of the day and before bedtime.
Scores ranged from 0 (no symptoms) to 4 (very severe symptoms).
Symptoms assessed over 24 weeks included change from baseline in the severity of evening cough, wheezing, shortness of breath and tightness of the chest, chest congestion, difficulty bringing up phlegm, overall evening symptom severity, and limitation of evening activities due to COPD symptoms
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Week 3 of treatment
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Change From Baseline in the Average Rating of Overall Night-time COPD Symptom Severity
大体时间:Week 3 of treatment
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Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI].
Scores ranged from 0 (no symptoms) to 4 (very severe symptoms).
The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]).
Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms
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Week 3 of treatment
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Change From Baseline in the Average Rating of COPD Symptoms Limiting Early Morning Activities
大体时间:Week 3 of treatment
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Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI].
Scores ranged from 0 (no symptoms) to 4 (very severe symptoms).
The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]).
Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms
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Week 3 of treatment
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Change From Baseline in the Average Rating of COPD Symptoms Limiting Evening Activities
大体时间:Week 3 of treatment
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The evening symptoms questionnaire was filled out after the second medication administration of the day and before bedtime.
Scores ranged from 0 (no symptoms) to 4 (very severe symptoms).
Symptoms assessed over 24 weeks included change from baseline in the severity of evening cough, wheezing, shortness of breath and tightness of the chest, chest congestion, difficulty bringing up phlegm, overall evening symptom severity, and limitation of evening activities due to COPD symptoms
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Week 3 of treatment
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Change From Baseline in Apnea-hypopnea Index (AHI) Per Hour of Total Sleep Time
大体时间:Week 3 of treatment
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The Apnea Hypopnea Index (AHI) is used to indicate the severity of obstructive sleep apnea.
The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep
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Week 3 of treatment
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Change From Baseline in Oxygen Desaturation Index (ODI) Per Hour of Total Sleep Time
大体时间:Week 3 of treatment
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The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.
In this study, any event with a 4% decrease in blood oxygen levels counted towards the total
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Week 3 of treatment
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Change From Baseline in Proportion of Sleep Stage REM as a Percentage of Total Sleep Time
大体时间:Week 3 of treatment
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Week 3 of treatment
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Change From Baseline in Sleep Efficiency
大体时间:Week 3 of treatment
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Sleep efficiency is calculated as the total sleep time as a proportion of total time in bed
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Week 3 of treatment
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Change From Baseline in Total Sleep Time
大体时间:Week 3 of treatment
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Week 3 of treatment
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Change From Baseline in Duration of at Least Moderate Activity
大体时间:Week 3 of treatment
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Moderate activity was defined as any physical activity >3 metabolic equivalents
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Week 3 of treatment
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Change From Baseline in Number of Steps Per Day
大体时间:Week 3 of treatment
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Week 3 of treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任:Anna Ribera, PhD、AstraZeneca Barcelona
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年4月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2014年5月5日
首先提交符合 QC 标准的
2014年5月30日
首次发布 (估计)
2014年6月3日
研究记录更新
最后更新发布 (估计)
2016年11月9日
上次提交的符合 QC 标准的更新
2016年9月20日
最后验证
2016年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的