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临床试验/NCT00523991
NCT00523991已完成4 期

A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy

Boehringer Ingelheim62 个研究点 分布在 8 个国家目标入组 457 人开始时间: 2007年4月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
457
试验地点
62
主要终点
Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

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
Double

入排标准

年龄范围
40 Years 至 80 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

placebo

Placebo Comparator

Oral inhalation once daily of placebo matching tiotropium via handihaler

干预措施: Placebo (Drug)

tiotropium

Experimental

Oral inhalation once daily of 18mcg tiotropium via handihaler

干预措施: tiotropium (Drug)

结局指标

主要结局

Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)

时间窗: baseline, week 24

Change = Week 24 Value - Baseline Value

次要结局

  • Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)(Baseline)
  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)(Baseline, week 8)
  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)(Baseline, week 16)
  • Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)(baseline, week 8, 180 minutes)
  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)(Baseline, week 24)
  • Peak Forced Expiratory Volume in 1 Second (Baseline)(Baseline)
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)(Baseline, week 8)
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)(Baseline, week 16)
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)(Baseline, week 24)
  • Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)(Baseline)
  • Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)(baseline, 30 minutes)
  • Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)(baseline, 60 minutes)
  • Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)(Baseline, 120 minutes)
  • Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)(Baseline, 180 minutes)
  • Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)(baseline, week 8, pre-dose)
  • Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)(Baseline, week 8, 30 minutes)
  • Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)(baseline, week 8, 60 minutes)
  • Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)(baseline, week 8, 120 minutes)
  • Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)(baseline, week 16, pre-dose)
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)(Baseline, week 16, 30 minutes)
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)(baseline, week 16, 60 minutes)
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)(baseline, week 16, 120 minutes)
  • Albuterol Use p.r.n. (Baseline)(baseline)
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)(baseline, week 16, 180 minutes)
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)(baseline, week 24, pre-dose)
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)(baseline, week 24, 30 minutes)
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)(baseline, week 24, 60 minutes)
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)(baseline, week 24, 120 minutes)
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)(baseline, week 24, 180 minutes)
  • FVC AUC0-3 at Baseline(baseline)
  • FVC AUC0-3 at Week 8 Minus Baseline(baseline, week 8)
  • FVC AUC0-3 at Week 16 Minus Baseline(baseline, week 16)
  • FVC AUC0-3 at Week 24 Minus Baseline(baseline, week 24)
  • Trough Forced Vital Capacity (Baseline)(baseline)
  • Change From Baseline in Trough Forced Vital Capacity (at Week 8)(baseline, week 8)
  • Change From Baseline in Trough Forced Vital Capacity (at Week 16)(baseline, week 16)
  • Change From Baseline in Albuterol Use p.r.n. - (Week 4)(baseline, week 4)
  • Change From Baseline in Trough Forced Vital Capacity (at Week 24)(baseline, week 24)
  • Peak Forced Vital Capacity (FVC) (Baseline)(baseline)
  • Change From Baseline in Peak Forced Vital Capacity (at Week 8)(baseline, week 8)
  • Change From Baseline in Peak Forced Vital Capacity (at Week 16)(baseline, week 16)
  • Change From Baseline in Peak Forced Vital Capacity (at Week 24)(baseline, week 24)
  • Forced Vital Capacity (Baseline, Pre-dose)(baseline)
  • Forced Vital Capacity (Baseline, 30 Minutes)(baseline, 30 minutes)
  • Forced Vital Capacity (Baseline, 60 Minutes)(baseline, 60 minutes)
  • Forced Vital Capacity (Baseline, 120 Minutes)(baseline, 120 minutes)
  • Forced Vital Capacity (Baseline, 180 Minutes)(baseline, 180 minutes)
  • Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)(baseline, week 8, pre-dose)
  • Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)(baseline, week 8, 30 minutes)
  • Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)(baseline, week 8, 60 minutes)
  • Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)(baseline, week 8, 120 minutes)
  • Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)(baseline, week 8, 180 minutes)
  • Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)(baseline, week 16, pre-dose)
  • Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)(baseline, week 16, 30 minutes)
  • Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)(baseline, week 16, 60 minutes)
  • Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)(baseline, week 16, 120 minutes)
  • Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)(baseline, week 16, 180 minutes)
  • Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)(baseline, week 24, pre-dose)
  • Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)(baseline, week 24, 30 minutes)
  • Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)(baseline, week 24, 60 minutes)
  • Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)(baseline, week 24, 120 minutes)
  • Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)(baseline, week 24, 180 minutes)
  • Change From Baseline in Albuterol Use p.r.n. - (Week 8)(baseline, week 8)
  • Change From Baseline in Albuterol Use p.r.n. -(Week 12)(baseline, week 12)
  • Change From Baseline in Albuterol Use p.r.n. - (Week 16)(baseline, week 16)
  • Change From Baseline in Albuterol Use p.r.n. -(Week 20)(baseline, week 20)
  • Change From Baseline in Albuterol Use p.r.n. - (Week 24)(baseline, week 24)
  • Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)(baseline)
  • Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)(week 12)
  • Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)(week 24)
  • Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)(baseline)
  • Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)(week 12)
  • Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)(week 24)
  • Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)(baseline)
  • Active Energy Expenditure (Baseline)(baseline)
  • Change From Baseline in Active Energy Expenditure (Week 4)(baseline, week 4)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)(baseline, week 4)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)(baseline, week 8)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)(baseline, week 12)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)(baseline, week 16)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)(baseline, week 20)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)(baseline, week 24)
  • Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health(baseline)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)(baseline, week 4)
  • Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day(baseline, week 4)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)(baseline, week 8)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)(baseline, week 12)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)(baseline, week 16)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)(baseline, week 20)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)(baseline, week 24)
  • Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)(baseline)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)(baseline, week 20)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)(baseline, week 24)
  • Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)(baseline)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)(baseline, week 4)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)(baseline, week 8)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)(baseline, week 12)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)(baseline, week 4)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)(baseline, week 8)
  • Change From Baseline in Active Energy Expenditure (Week 8)(baseline, week 8)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)(baseline, week 16)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)(baseline, week 20)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)(baseline, week 24)
  • Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day(baseline)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)(baseline, week 12)
  • Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)(baseline, week 16)
  • Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day(baseline, week 4)
  • Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day(baseline, week 8)
  • Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day(baseline, week 12)
  • Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day(baseline, week 16)
  • Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day(baseline, week 20)
  • Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day(baseline, week 24)
  • Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day(baseline)
  • Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day(baseline, week 8)
  • Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day(baseline, week 12)
  • Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day(baseline, week 16)
  • Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day(baseline, week 24)
  • Number of Participants With Healthy Lifestyle (Week 4)(week 4)
  • Number of Participants With Healthy Lifestyle (Baseline)(baseline)
  • Change From Baseline in Active Energy Expenditure (Week 12)(baseline, week 12)
  • Change From Baseline in Active Energy Expenditure (Week 16)(baseline, week 16)
  • Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day(baseline, week 20)
  • Number of Participants With Healthy Lifestyle (Week 8)(week 8)
  • Change From Baseline in Active Energy Expenditure (Week 20)(baseline, week 20)
  • Change From Baseline in Active Energy Expenditure (Week 24)(baseline, week 24)
  • Number of Steps Per Day (Baseline)(baseline)
  • Number of Participants With Healthy Lifestyle (Week 12)(week 12)
  • Number of Participants With Healthy Lifestyle (Week 16)(week 16)
  • Number of Participants With Healthy Lifestyle (Week 20)(week 20)
  • Number of Participants With Healthy Lifestyle (Week 24)(week 24)
  • Change From Baseline in Number of Steps Per Day (Week 4)(baseline, week 4)
  • Change From Baseline in Number of Steps Per Day(Week 8)(baseline, week 8)
  • Change From Baseline in Number of Steps Per Day (Week 12)(baseline, week 12)
  • Change From Baseline in Number of Steps Per Day (Week 16)(baseline, week 16)
  • Change From Baseline in Number of Steps Per Day (Week 20)(baseline, week 20)
  • Change From Baseline in Number of Steps Per Day (Week 24)(baseline, week 24)

研究者

申办方类型
Industry

研究点 (62)

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