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临床试验/NCT00359788
NCT00359788已完成4 期

A Randomized, Double-blind, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium 18 mcg Daily to Combivent MDI 2 Actuations Qid in COPD Patients Previously Prescribed Combivent MDI

Boehringer Ingelheim31 个研究点 分布在 1 个国家目标入组 349 人开始时间: 2006年7月最近更新:
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试验速览

阶段
4 期
状态
已完成
入组人数
349
试验地点
31
主要终点
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks
研究概览研究设计入排标准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

The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Treatment

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

  • •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Age: greater than or equal to 40 years
  • •Current or ex-smoker with a >= 10 pack-year smoking history
  • •Use of Combivent® Metered Dose Inhaler (MDI)for >= 1 month prior to Visit 1
  • •Spirometric criteria (determined at study visits):
  • •Post-bronchodilator Forced Expiratory Volume in one second (FEV1) <= 70% (Visit 1)
  • •Pre-bronchodilator FEV1 <= 65% of predicted and FEV1/Forced Vital Capacity (FVC) <= 70% (Visit 2)

排除标准

  • •Clinical history of asthma
  • •History of thoracotomy with pulmonary resection
  • •History of Cystic Fibrosis, alpha 1 antitrypsin deficiency or interstitial lung disease
  • •Daytime use of oxygen therapy for > 1 hour per day or if unable to abstain fr om using oxygen during Pulmonary Function Tests
  • •Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
  • •Recent history 6 months or less of Myocardial Infarction
  • •Unstable or life-threatening cardiac arrhythmias
  • •Hospitalization for Congestive Heart Failure during past year
  • •Malignancy for which patient is receiving chemo or radiation therapy
  • •Pregnant or nursing women
  • •Known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose
  • •Use of SPIRIVA® 3 months prior to Visit 1
  • •Symptomatic of prostatic hypertrophy or bladder neck obstruction
  • •Known narrow- angle glaucoma
  • •Participating in a pulmonary rehab program within 4 weeks of Visit 1

结局指标

主要结局

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks

时间窗: Baseline and 12 Weeks

Trough FEV1 is measured 10 minutes before drug administration

Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks

时间窗: Baseline and 12 Weeks

Average hourly FEV1 AUC0-6 minus baseline FEV1

次要结局

  • FVC at 2 Hours on Day 1(2 hour)
  • FVC at 3 Hours on Day 1(3 hour)
  • FVC at 4 Hours on Day 1(4 hour)
  • FVC at 6 Hours on Day 1(6 hour)
  • FVC at -10 Minutes at Week 6(10 minutes before dosing)
  • FVC at 15 Minutes at Week 6(15 minutes)
  • Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6(Baseline and week 6)
  • Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1(Day 1)
  • Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6(Baseline and 6 weeks)
  • Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12(Baseline and 12 weeks)
  • Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks(Baseline and 12 weeks)
  • Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks(Baseline and 12 Weeks)
  • Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks(Baseline and 6 weeks)
  • Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1(Day 1)
  • Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks(Baseline and 6 Weeks)
  • Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks(Baseline and 6 Weeks)
  • Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1(Day 1 (after first dose))
  • FVC at 30 Minutes on Day 1(30 minutes)
  • FVC at 1 Hour on Day 1(1 hour)
  • Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1(Day 1)
  • Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6(baseline and 6 Weeks (after first dose))
  • Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12(Baseline and 12 Weeks)
  • FEV1 at 15 Minutes on Day 1(15 minutes)
  • FEV1 at 30 Minutes on Day 1(30 minutes)
  • FEV1 at 1 Hour on Day 1(1 hour)
  • FEV1 at 2 Hours on Day 1(2 hour)
  • FEV1 at 3 Hours on Day 1(3 hour)
  • FEV1 at 4 Hours on Day 1(4 hour)
  • FEV1 at 6 Hours on Day 1(6 hours)
  • FEV1 at -10 Minutes at Week 6(10 minutes before dosing)
  • FEV1 at 15 Minutes at Week 6(15 minutes)
  • FEV1 at 30 Minutes at Week 6(30 minutes)
  • FEV1 at 1 Hour at Week 6(1 hour)
  • FEV1 at 2 Hours at Week 6(2 hour)
  • FEV1 at 3 Hours at Week 6(3 hour)
  • FEV1 at 4 Hours at Week 6(4 hour)
  • FEV1 at 6 Hours at Week 6(6 hour)
  • FEV1 at -10 Minutes at Week 12(10 minutes before dosing)
  • FEV1 at 15 Minutes at Week 12(15 minutes)
  • FEV1 at 30 Minutes at Week 12(30 minutes)
  • FEV1 at 1 Hour at Week 12(1 hour)
  • FEV1 at 2 Hours at Week 12(2 hour)
  • FEV1 at 3 Hours at Week 12(3 hour)
  • FEV1 at 4 Hours at Week 12(4 hour)
  • FEV1 at 6 Hours at Week 12(6 hour)
  • FVC at 15 Minutes on Day 1(15 minutes)
  • FVC at 30 Minutes at Week 6(30 minutes)
  • FVC at 1 Hour at Week 6(1 hour)
  • FVC at 2 Hours at Week 6(2 hour)
  • FVC at 3 Hours at Week 6(3 hour)
  • FVC at 4 Hours at Week 6(4 hour)
  • FVC at 6 Hours at Week 6(6 hour)
  • FVC at -10 Minutes at Week 12(10 minutes before dosing)
  • FVC at 15 Minutes at Week 12(15 minutes)
  • FVC at 30 Minutes at Week 12(30 minutes)
  • FVC at 1 Hour at Week 12(1 hour)
  • FVC at 2 Hours at Week 12(2 hour)
  • FVC at 3 Hours at Week 12(3 hour)
  • FVC at 4 Hours at Week 12(4 hour)
  • FVC at 6 Hours at Week 12(6 hour)
  • Day Time Albuterol Use During Week 1(Week 1)
  • Day Time Albuterol Use During Week 2(Week 2)
  • Day Time Albuterol Use During Week 3(Week 3)
  • Day Time Albuterol Use During Week 4(Week 4)
  • Day Time Albuterol Use During Week 5(Week 5)
  • Day Time Albuterol Use During Week 6(Week 6)
  • Night Time Albuterol Use During Week 3(Week 3)
  • Night Time Albuterol Use During Week 4(Week 4)
  • Night Time Albuterol Use During Week 5(Week 5)
  • Night Time Albuterol Use During Week 11(Week 11)
  • Day Time Albuterol Use During Week 7(Week 7)
  • Day Time Albuterol Use During Week 8(Week 8)
  • Day Time Albuterol Use During Week 12(Week 12)
  • Night Time Albuterol Use During Week 7(Week 7)
  • Night Time Albuterol Use During Week 8(Week 8)
  • Day Time Albuterol Use During Week 10(Week 10)
  • Day Time Albuterol Use During Week 9(Week 9)
  • Night Time Albuterol Use During Week 2(Week 2)
  • Night Time Albuterol Use During Week 9(Week 9)
  • Night Time Albuterol Use During Week 10(Week 10)
  • Day Time Albuterol Use During Week 11(Week 11)
  • Night Time Albuterol Use During Week 1(Week 1)
  • Morning Peak Expiratory Flow Rate (PEFR) at Week 1(Week 1)
  • Morning PEFR at Week 2(Week 2)
  • Morning PEFR at Week 3(Week 3)
  • Morning PEFR at Week 4(Week 4)
  • Morning PEFR at Week 5(Week 5)
  • Morning PEFR at Week 6(Week 6)
  • Morning PEFR at Week 7(Week 7)
  • Night Time Albuterol Use During Week 6(Week 6)
  • Night Time Albuterol Use During Week 12(Week 12)
  • Morning PEFR at Week 8(Week 8)
  • Morning PEFR at Week 9(Week 9)
  • Morning PEFR at Week 10(Week 10)
  • Morning PEFR at Week 11(Week 11)
  • Morning PEFR at Week 12(Week 12)
  • Evening PEFR at Week 1(Week 1)
  • Evening PEFR at Week 2(Week 2)
  • Evening PEFR at Week 3(Week 3)
  • Evening PEFR at Week 4(Week 4)
  • Evening PEFR at Week 5(Week 5)
  • Evening PEFR at Week 6(Week 6)
  • Evening PEFR at Week 7(Week 7)
  • Evening PEFR at Week 8(Week 8)
  • Evening PEFR at Week 9(Week 9)
  • Evening PEFR at Week 10(Week 10)
  • Evening PEFR at Week 11(Week 11)
  • Evening PEFR at Week 12(Week 12)
  • Patient Global Evaluation(Week 12)
  • Physician Global Evaluation(Week 12)

研究者

申办方类型
Industry

研究点 (31)

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