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Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (GLOW6)

2014年11月12日 更新者：Novartis Pharmaceuticals

A 12-week Multi-center, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of the Co-administration of NVA237 + Indacaterol Once Daily vs. Indacaterol Once Daily in Patients With Moderate to Severe COPD

This study assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

449

阶段

  • 第三阶段

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

  • 俄罗斯联邦
      • Moscow、俄罗斯联邦、125315
        • Novartis Investigative Site
      • N.Novgorod、俄罗斯联邦、603126
        • Novartis Investigative Site
      • Nizhny Novgorod、俄罗斯联邦、603018
        • Novartis Investigative Site
      • Saratov、俄罗斯联邦、410012
        • Novartis Investigative Site
  • 保加利亚
      • Pleven、保加利亚、5800
        • Novartis Investigative Site
      • Plovdiv、保加利亚、4002
        • Novartis Investigative Site
      • Ruse、保加利亚、7002
        • Novartis Investigative Site
      • Sofia、保加利亚、1431
        • Novartis Investigative Site
      • Sofia、保加利亚、1606
        • Novartis Investigative Site
      • Sofia、保加利亚、1000
        • Novartis Investigative Site
      • Stara Zagora、保加利亚、6000
        • Novartis Investigative Site
      • Varna、保加利亚、9010
        • Novartis Investigative Site
  • 匈牙利
      • Budapest、匈牙利、1121
        • Novartis Investigative Site
      • Budapest、匈牙利、1046
        • Novartis Investigative Site
      • Deszk、匈牙利、6772
        • Novartis Investigative Site
      • Erd、匈牙利、H-2030
        • Novartis Investigative Site
      • Godollo、匈牙利、2100
        • Novartis Investigative Site
  • 希腊
      • Athens、希腊、11527
        • Novartis Investigative Site
    • GR
      • Athens、GR、希腊、115 27
        • Novartis Investigative Site
      • Athens、GR、希腊、106 76
        • Novartis Investigative Site
      • Thessaloniki、GR、希腊、564 03
        • Novartis Investigative Site
  • 斯洛伐克
      • Bratislava、斯洛伐克、826 06
        • Novartis Investigative Site
      • Kosice、斯洛伐克、040 01
        • Novartis Investigative Site
      • Kralovsky Chlmec、斯洛伐克、077 01
        • Novartis Investigative Site
    • Slovak Republic
      • Bardejov、Slovak Republic、斯洛伐克、085 01
        • Novartis Investigative Site
      • Bojnice、Slovak Republic、斯洛伐克、972 01
        • Novartis Investigative Site
      • Liptovsky Hradok、Slovak Republic、斯洛伐克、033 01
        • Novartis Investigative Site
    • Slovensko
      • Námestovo、Slovensko、斯洛伐克、02901
        • Novartis Investigative Site
  • 比利时
      • Brussel、比利时、1090
        • Novartis Investigative Site
      • Bruxelles、比利时、1070
        • Novartis Investigative Site
      • Genk、比利时、3600
        • Novartis Investigative Site
      • Gilly、比利时、6060
        • Novartis Investigative Site
      • Gosselies、比利时、6041
        • Novartis Investigative Site
      • Hasselt、比利时、3500
        • Novartis Investigative Site
      • Herentals、比利时、2200
        • Novartis Investigative Site
      • Jambes、比利时、5100
        • Novartis Investigative Site
      • Liège、比利时、4000
        • Novartis Investigative Site
      • Luxembourg、比利时、1210
        • Novartis Investigative Site
      • Malmedy/Bellevaux-Ligneuville、比利时、4960
        • Novartis Investigative Site
      • Montigny-le-tilleul、比利时、6110
        • Novartis Investigative Site
      • Turnhout、比利时、2300
        • Novartis Investigative Site
      • Yvoir、比利时、5530
        • Novartis Investigative Site
  • 火鸡
      • Ankara、火鸡、06490
        • Novartis Investigative Site
      • Istanbul、火鸡、34854
        • Novartis Investigative Site
      • Istanbul、火鸡
        • Novartis Investigative Site
      • Kocaeli、火鸡、41380
        • Novartis Investigative Site
      • Mersin、火鸡、33079
        • Novartis Investigative Site
      • Yenisehir/Izmir、火鸡、35110
        • Novartis Investigative Site
  • 爱尔兰
    • Cork
      • Wilton、Cork、爱尔兰
        • Novartis Investigative Site
  • 英国
      • Bath、英国、BA1 2SR
        • Novartis Investigative Site
      • Bexhill-on-Sea、英国、TN40 1JJ
        • Novartis Investigative Site
      • Blackpool、英国、FY3 7EN
        • Novartis Investigative Site
      • Bradford、英国、BD9 6RJ
        • Novartis Investigative Site
      • Cambridge、英国、CB7 5JD
        • Novartis Investigative Site
      • Chesterfield、英国、S40 4AA
        • Novartis Investigative Site
      • Huntingdon、英国、PE29 6NT
        • Novartis Investigative Site
      • Manchester、英国、M20 2RN
        • Novartis Investigative Site
      • Newcastle-upon-Tyne、英国、NE7 7DN
        • Novartis Investigative Site
      • Newton Aycliffe、英国、DL5 4SE
        • Novartis Investigative Site
      • Reading、英国、RG7 3SQ
        • Novartis Investigative Site
      • Southbourne、英国
        • Novartis Investigative Site
      • Telford、英国、TF1 6TF
        • Novartis Investigative Site
      • Watford、英国、WD25 0EA
        • Novartis Investigative Site
      • Wiltshire、英国、SN15 2SB
        • Novartis Investigative Site
    • County Durham
      • Burnhope、County Durham、英国、DH7 0BD
        • Novartis Investigative Site
    • Suffolk
      • Alderton、Suffolk、英国、IP12 3DA
        • Novartis Investigative Site
    • Warwickshire
      • Atherstone、Warwickshire、英国、CV9 1EU
        • Novartis Investigative Site
      • Leamington Spa、Warwickshire、英国、CV32 4RA
        • Novartis Investigative Site
    • Yorkshire
      • Strensall、Yorkshire、英国、YO32 5UA
        • Novartis Investigative Site
  • 西班牙
      • Barcelona、西班牙、08025
        • Novartis Investigative Site
    • Andalucia
      • Malaga、Andalucia、西班牙、29010
        • Novartis Investigative Site
    • Asturias
      • Gijon、Asturias、西班牙、33290
        • Novartis Investigative Site
    • Cantabria
      • Torrelavega、Cantabria、西班牙、39300
        • Novartis Investigative Site
    • Castilla la Mancha
      • Illescas、Castilla la Mancha、西班牙、45200
        • Novartis Investigative Site
    • Castilla y Leon
      • Ponferrada、Castilla y Leon、西班牙、24400
        • Novartis Investigative Site
    • Cataluña
      • Centelles、Cataluña、西班牙、08540
        • Novartis Investigative Site
      • Salt、Cataluña、西班牙、17190
        • Novartis Investigative Site
      • Sant Boi de Llobregat、Cataluña、西班牙、08830
        • Novartis Investigative Site
      • Viladecans、Cataluña、西班牙
        • Novartis Investigative Site
    • Extremadura
      • Mérida、Extremadura、西班牙、06800
        • Novartis Investigative Site

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:

  • Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
  • Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 0.70 at screening.
  • Current or ex-smokers who have a smoking history of at least 10 pack years
  • Symptomatic patients according to daily diary data.

Exclusion Criteria:

  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential unless using adequate contraception.
  • Patients with Type I or uncontrolled Type II diabetes.
  • Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
  • Patients with paroxysmal (e.g. intermittent) atrial fibrillation
  • Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)

Other protocol-defined inclusion/exclusion criteria may apply.

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：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：NVA237 + indacaterol
药品：NVA237 50 µg and indacaterol 150 µg
NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
其他名称：
  • Glycopyrronium Bromide
安慰剂比较：Placebo to NVA237 + indacaterol
药品：Placebo to NVA237 and indacaterol 150 µg
Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Trough Forced Expiratory Volume at 1 Second (FEV1)
大体时间：12 weeks
Centralized spirometry according to internationally accepted standards was used. The model contained treatment, baseline smoking status and baseline inhaled corticosteroid (ICS) use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in region as a random effect. If trough FEV1 was missing at week 12, the latest non-missing pre-dose trough FEV1 (the mean of 45 and 15 min pre-dose measurements) from day 29, 57 or 84) was carried forward. These measurements had to have been taken before the next dose of study medication. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
12 weeks

次要结果测量

结果测量
措施说明
大体时间
FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
大体时间：12 weeks
Centralized spirometry was used according to internationally accepted standards was used. The trapezoidal rule was applied to calculate FEV1 Area Under the Curve (AUC) and then normalized to the length of time. Whether the participants had complete or incomplete FEV1 assessments in respective time ranges, their AUCs were calculated based on the existing FEV1 measurements (i.e., the missing FEV1 measurements were not interpolated). Specifically, for those participants who had a FEV1 assessment at only one time-point, their AUC was approximated by the observed FEV1. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
12 weeks
Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks
大体时间：12 weeks
Centralized spirometry was used according to internationally accepted standards was used. Peak FEV1 was defined as the maximum FEV1 during the first 4 hours post morning dosing. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in a region as a random effect. If all FEV1 measurements were missing from 30 minutes onward, the peak FEV1 was not calculated. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
12 weeks
FEV1 at Individual Time-points
大体时间：Day 1, Day 29, Day 57 and Days 84/85
Centralized spirometry according to internationally accepted standards was used. FEV1 was measured at all post-dose time points up to 4 hours, and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
Day 1, Day 29, Day 57 and Days 84/85
Forced Vital Capacity (FVC) at Individual Time-points
大体时间：Day 1, Day 29, Day 57 and Days 84/85
FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FVC, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FVC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.
Day 1, Day 29, Day 57 and Days 84/85
Inspiratory Capacity (IC) at Individual Time-points
大体时间：Day 1, Days 84/85
Inspiratory Capacity (IC) was measured at 20 min pre-dose and at post-dose at 25 minutes, 1 hour 55 minutes, 3 hours 55 minutes and 23 hours 40 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of IC, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. IC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.
Day 1, Days 84/85
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication
大体时间：Baseline, 12 weeks
The number of puffs of rescue medication taken in the previous 12 hours was recorded in the patient diary in the morning and evening. The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening), then a half day was used in the denominator.
Baseline, 12 weeks
Transitional Dyspnea Index (TDI) Focal Score
大体时间：baseline, 12 weeks
Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during treatment using the Transitional Dyspnea Index (TDI). Analysis was done via mixed model. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of 1 is considered a minimal clinically important difference.
baseline, 12 weeks
Change From Baseline in Mean Daily Total and Individual Symptom Scores
大体时间：Baseline, 12 weeks
The symptoms (respiratory, cough, wheeze, sputum color, sputum production, breathlessness, sore throat, nasal discharge or congestion, and fever) for the whole active treatment period was analyzed using a mixed model, which contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline symptom score, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. Each symptom was scored as 0, 1, 2 or 3 where the description for each score varied. For each of the symptoms, the range of scores from 0 to 3 represented an increase in symptoms where 0 represented little to no symptom and 3 represented severe or worst symptom. The total symptom score, which is the sum of the individual scores, ranged from 0 (best possible outcome) to 27 (worst possible outcome).
Baseline, 12 weeks
Number of Participants With Adverse Events and Serious Adverse Events
大体时间：12 weeks
All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.
12 weeks

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

Novartis Pharmaceuticals

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。

一般刊物

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

2012年5月1日

初级完成 (实际的)

2013年1月1日

研究完成 (实际的)

2013年1月1日

研究注册日期

首次提交

2012年5月21日

首先提交符合 QC 标准的

2012年5月21日

首次发布 (估计)

2012年5月23日

研究记录更新

最后更新发布 (估计)

2014年11月14日

上次提交的符合 QC 标准的更新

2014年11月12日

最后验证

2014年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CNVA237A2316
  • 2011-005673-23 (EudraCT编号)

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.

NVA237 50 µg and indacaterol 150 µg的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Saudi Arabia

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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