此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

2015年1月15日 更新者：Novartis Pharmaceuticals

A Multicenter, Randomized, Double-blind, Placebo-controlled, 12-week Treatment, Parallel-group Study to Assess the Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate (75 and 150 µg o.d.) in Patients With Persistent Asthma

To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.

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)

335

阶段

  • 阶段2

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

  • 保加利亚
      • Lovech、保加利亚、5500
        • Novartis Investigative Site
      • 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、1233
        • Novartis Investigative Site
      • Sofia、保加利亚、1606
        • Novartis Investigative Site
      • Sofia、保加利亚、1612
        • Novartis Investigative Site
      • Sofia、保加利亚、1000
        • Novartis Investigative Site
      • Sofia、保加利亚、1234
        • Novartis Investigative Site
      • Sofia、保加利亚、1463
        • Novartis Investigative Site
      • Varna、保加利亚、9000
        • Novartis Investigative Site
      • Varna、保加利亚、9020
        • Novartis Investigative Site
      • Veliko Tarnovo、保加利亚、5000
        • Novartis Investigative Site
  • 加拿大
    • Ontario
      • Brampton、Ontario、加拿大、L6T 0G1
        • Novartis Investigative Site
      • Downsview、Ontario、加拿大、M3N 2Z9
        • Novartis Investigative Site
      • Etobicoke、Ontario、加拿大、M9V 4B4
        • Novartis Investigative Site
      • Grimsby、Ontario、加拿大、L3M 1P3
        • Novartis Investigative Site
      • Hamilton、Ontario、加拿大、L8N 3Z5
        • Novartis Investigative Site
      • Newmarket、Ontario、加拿大、L3Y 5G8
        • Novartis Investigative Site
      • Toronto、Ontario、加拿大、M5T 3A9
        • Novartis Investigative Site
      • Woodstock、Ontario、加拿大、N4S 5P5
        • Novartis Investigative Site
    • Quebec
      • Montreal、Quebec、加拿大、H4J 1C5
        • Novartis Investigative Site
      • Pointe-Claire、Quebec、加拿大、H9R 4S3
        • Novartis Investigative Site
      • St-Romuald、Quebec、加拿大、G6W 5M6
        • Novartis Investigative Site
      • Ste-Foy、Quebec、加拿大、G1W 4R4
        • Novartis Investigative Site
  • 大韩民国
      • Seoul、大韩民国、120-752
        • Novartis Investigative Site
      • Seoul、大韩民国、158-710
        • Novartis Investigative Site
      • Seoul、大韩民国、152-703
        • Novartis Investigative Site
      • Seoul、大韩民国、100-032
        • Novartis Investigative Site
    • Chungbuk
      • Cheongju、Chungbuk、大韩民国、361 711
        • Novartis Investigative Site
    • Gangwon-Do
      • Wonju、Gangwon-Do、大韩民国、220-701
        • Novartis Investigative Site
    • Korea
      • Seoul、Korea、大韩民国、110 744
        • Novartis Investigative Site
  • 德国
      • Bad Woerishofen、德国、86825
        • Novartis Investigative Site
      • Bonn、德国、53123
        • Novartis Investigative Site
      • Dortmund、德国、44263
        • Novartis Investigative Site
      • Dresden、德国、01307
        • Novartis Investigative Site
      • Frankfurt、德国、60596
        • Novartis Investigative Site
      • Lübeck、德国、23552
        • Novartis Investigative Site
      • Mainz、德国、55131
        • Novartis Investigative Site
      • Muenchen、德国、81677
        • Novartis Investigative Site
      • Wiesbaden、德国、65187
        • Novartis Investigative Site
      • Wiesloch、德国、69168
        • Novartis Investigative Site
  • 斯洛伐克
      • Dunajska Streda、斯洛伐克、929 01
        • Novartis Investigative Site
      • Komarno、斯洛伐克、945 01
        • Novartis Investigative Site
      • Kosice、斯洛伐克、040 01
        • Novartis Investigative Site
      • Liptovsky Hradok、斯洛伐克、033 01
        • Novartis Investigative Site
      • Liptovsky Mikulas、斯洛伐克、031 23
        • Novartis Investigative Site
      • Nove Zamky、斯洛伐克、940 01
        • Novartis Investigative Site
      • Rimavska Sobota、斯洛伐克、979 01
        • Novartis Investigative Site
      • Spisská Nová Ves、斯洛伐克、052 01
        • Novartis Investigative Site
      • Topolcany、斯洛伐克、955 01
        • Novartis Investigative Site
      • Vysne Hagy、斯洛伐克、5984
        • Novartis Investigative Site
      • Zvolen、斯洛伐克、960 01
        • Novartis Investigative Site
    • Slovak Republic
      • Banska Bystrica、Slovak Republic、斯洛伐克、975 17
        • Novartis Investigative Site
      • Bardejov、Slovak Republic、斯洛伐克、085 01
        • Novartis Investigative Site
    • Slovak republic
      • Levice、Slovak republic、斯洛伐克、934 01
        • Novartis Investigative Site
  • 日本
      • Fukuoka、日本、811-1394
        • Novartis Investigative Site
      • Gifu、日本、502-8558
        • Novartis Investigative Site
    • Fukuoka
      • Yanagawa、Fukuoka、日本、832-0059
        • Novartis Investigative Site
    • Hokkaido
      • Obihiro、Hokkaido、日本、080-0805
        • Novartis Investigative Site
      • Sapporo-city、Hokkaido、日本、060-0061
        • Novartis Investigative Site
    • Hyogo
      • Himeji-city、Hyogo、日本、672-8064
        • Novartis Investigative Site
    • Hyogo-Ken
      • Ako-shi、Hyogo-Ken、日本、678-0241
        • Novartis Investigative Site
    • Ibaraki
      • Naka-gun、Ibaraki、日本、319-1113
        • Novartis Investigative Site
    • Kagawa
      • Sakaide、Kagawa、日本、762-0031
        • Novartis Investigative Site
    • Kyoto-Fu
      • Kyoto-shi、Kyoto-Fu、日本、615-8256
        • Novartis Investigative Site
    • Mie
      • Tsu、Mie、日本、514-1101
        • Novartis Investigative Site
    • Oita
      • Beppu、Oita、日本、874-0937
        • Novartis Investigative Site
    • Oita-Ken
      • Oita-shi、Oita-Ken、日本、870-0021
        • Novartis Investigative Site
    • Osaka
      • Kishiwada、Osaka、日本、596-8501
        • Novartis Investigative Site
    • Tokyo
      • Chuo-ku、Tokyo、日本、103-0027
        • Novartis Investigative Site
      • Cyuo-ku、Tokyo、日本、104-8560
        • Novartis Investigative Site
      • Itabashi-ku、Tokyo、日本、173-8610
        • Novartis Investigative Site
      • Kiyose-city、Tokyo、日本、204-8585
        • Novartis Investigative Site
      • Setagaya-ku、Tokyo、日本、158-0097
        • Novartis Investigative Site
    • Tokyo-To
      • Machida-shi、Tokyo-To、日本、194-0023
        • Novartis Investigative Site
      • Ota-ku、Tokyo-To、日本、144-0035
        • Novartis Investigative Site
    • Yamagata
      • Yonezawa、Yamagata、日本、992-0045
        • Novartis Investigative Site
  • 波兰
      • Bialystok、波兰、15-461
        • Novartis Investigative Site
      • Bienkowka、波兰、34-212
        • Novartis Investigative Site
      • Bydgoszcz、波兰、85-046
        • Novartis Investigative Site
      • Gdansk、波兰、80-958
        • Novartis Investigative Site
      • Krakow、波兰、31-023
        • Novartis Investigative Site
      • Lodz、波兰、90-302
        • Novartis Investigative Site
      • Lodz、波兰、90-242
        • Novartis Investigative Site
      • Lublin、波兰、20-637
        • Novartis Investigative Site
      • Lublin、波兰、20-044
        • Novartis Investigative Site
      • Torun、波兰、87-100
        • Novartis Investigative Site
      • Wroclaw、波兰、50-088
        • Novartis Investigative Site
      • Znin、波兰、88-400
        • Novartis Investigative Site
  • 荷兰
      • Rotterdam、荷兰、3045 PM
        • Novartis Investigative Site
      • Sittard-Geleen、荷兰、6162 BG
        • 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

18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 persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
  • Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks
  • Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value
  • Patients who demonstrate an increase of >= 12% and 200 mL in FEV1
  • ACQ-5 score ≥ 1.5

Exclusion Criteria:

  • Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
  • Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
  • Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：indacaterol acetate 75 µg

indacaterol acetate 75 µg od delivered via Concept 1 inhaler

Background therapy: mometasone furoate 200 mcg od
药品：indacaterol
indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler
药品：mometasone furoate
via Twisthaler inhaler
实验性的：indacaterol acetate 150 µg

indacaterol acetate 150 µg od delivered via Concept 1 inhaler

Background therapy: mometasone furoate 200 mcg od
药品：indacaterol
indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler
药品：mometasone furoate
via Twisthaler inhaler
安慰剂比较：placebo

placebo delivered via Concept 1 inhaler

Background therapy: mometasone furoate 200 mcg od
药品：mometasone furoate
via Twisthaler inhaler
药品：placebo
placebo delivered via Concept 1 inhaler

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 in One Second (FEV1) After 12 Weeks (Day 85)
大体时间：after 12 weeks (Day 85)
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)
after 12 weeks (Day 85)

次要结果测量

结果测量
措施说明
大体时间
Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)
大体时间：aftert 12 weeks (Day 85)
The Asthma Control Questionnaire (ACQ-5) is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.
aftert 12 weeks (Day 85)
Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.
大体时间：Day 15, Day 29 and Day 57
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 2 weeks (Day 15), 4 weeks (Day 29), and 8 weeks (Day 57) of treatment.
Day 15, Day 29 and Day 57
Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points
大体时间：Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points
Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
大体时间：Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.
Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
大体时间：Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards.
Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)
大体时间：Day 1, 2 Weeks, 12 Weeks
Forced Expiratory Volume in 1 second (FEV1)/Area Under the Curve(AUC) was measured via spirometry conducted according to internationally accepted standards.FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1, 2 Weeks (Day 14) and 12 Weeks (Day84) and defined as average of FEV1 at specified timepoints above.
Day 1, 2 Weeks, 12 Weeks
Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)
大体时间：Day 1, 2 weeks (Day 14), 12 weeks (Day 84)
Peak Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.
Day 1, 2 weeks (Day 14), 12 weeks (Day 84)
Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment
大体时间：after 4 weeks (Day 29) and after 8 weeks (Day 57)
The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
after 4 weeks (Day 29) and after 8 weeks (Day 57)
Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.
大体时间：baseline, 4weeks, 8 weeks and 12 weeks
PEFR is measured with portable spirometer by participants every morning and evening at home.
baseline, 4weeks, 8 weeks and 12 weeks
The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment
大体时间：12 weeks
Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime.
12 weeks
Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment
大体时间：4 Weeks, 12 Weeks
The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
4 Weeks, 12 Weeks
Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
大体时间：12 weeks
Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
12 weeks
The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
大体时间：12 weeks
Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. Number of the asthma exacerbation will be analyzed by the negative binomial regression including treatment, history of asthma exacerbation in the 12 months prior to screening and region as factors and FEV1 prior to inhalation and FEV1 30 min post inhalation of salbutamol/albuterol (components of SABA reversibility) as covariates. The estimates are obtained from the model and so we cannot specify a formula.
12 weeks
Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
大体时间：12 weeks
Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
12 weeks
The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
大体时间：12 weeks
The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
12 weeks
Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period
大体时间：12 weeks
Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
12 weeks
The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period
大体时间：12 weeks
The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
12 weeks
Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period
大体时间：12 weeks
Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma exacerbations.SCS includes Intramuscular (IM), Intravenous (IV) and Oral. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
12 weeks
Plasma Indacaterol Concentrations at Day 1 and Day 14
大体时间：Day 1 and Day 14
Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup
Day 1 and Day 14

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

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8月1日

初级完成 (实际的)

2013年7月1日

研究完成 (实际的)

2013年7月1日

研究注册日期

首次提交

2012年4月23日

首先提交符合 QC 标准的

2012年5月29日

首次发布 (估计)

2012年6月1日

研究记录更新

最后更新发布 (估计)

2015年1月27日

上次提交的符合 QC 标准的更新

2015年1月15日

最后验证

2015年1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

  • CQMF149E2203
  • 2012-000520-18 (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.

indacaterol的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Serbia

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅