NCT00400153已完成3 期
Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,480
- 试验地点
- 180
- 主要终点
- FEV1 AUC0-4 at Day 85
研究概览
简要总结
The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).
排除标准
- •Patients with significant diseases other than COPD that may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study, with a history of asthma or allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy or using oral corticosteroid me dication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day will be excluded.
研究组 & 干预措施
COMBIVENT Respimat 20/100 mcg
Experimental
干预措施: Combivent Respimat (20 mcg/100 mcg) (Drug)
COMBIVENT Respimat 20/100 mcg
Experimental
干预措施: Placebo via corresponding inhaler for blinding purposes (Drug)
COMBIVENT CFC-MDI 36/206 mcg
Experimental
干预措施: COMBIVENT MDI (36/206 mcg) (Drug)
COMBIVENT CFC-MDI 36/206 mcg
Experimental
干预措施: Placebo via corresponding inhaler for blinding purposes (Drug)
Ipratropium Respimat 20 mcg
Experimental
干预措施: Atrovent Respimat (20 mcg) (Drug)
Ipratropium Respimat 20 mcg
Experimental
干预措施: Placebo via corresponding inhaler for blinding purposes (Drug)
结局指标
主要结局
FEV1 AUC0-4 at Day 85
时间窗: Before drug administration to 4 hours after drug administration on Day 85
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85
FEV1 AUC4-6 at Day 85
时间窗: Between 4 hours and 6 hours after drug administration on Day 85
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85
FEV1 AUC0-6 at Day 85
时间窗: Before drug administration to 6 hours after drug administration on Day 85
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85
次要结局
- FEV1 AUC0-6 at Day 1(Before drug administration to 6 hours after drug administration on Day 1)
- FEV1 AUC0-6 at Day 29(Before drug administration to 6 hours after drug administration on Day 29)
- FEV1 AUC0-6 at Day 57(Before drug administration to 6 hours after drug administration on Day 57)
- FEV1 AUC0-4 at Day 1(Before drug administration to 4 hours after drug administration on Day 1)
- FEV1 AUC4-6 at Day 1(Between 4 hours and 6 hours after drug administration on Day 1)
- FEV1 AUC0-4 at Day 29(Before drug administration to 4 hours after drug administration on Day 29)
- FEV1 AUC0-4 at Day 57(Before drug administration to 4 hours after drug administration on Day 57)
- FEV1 AUC4-6 at Day 29(Between 4 hours and 6 hours after drug administration on Day 29)
- Peak FEV1 Response at Day 1(Within the first 2-hour post-treatment interval on Day 1)
- Time to Onset of Therapeutic FEV1 Response at Day 1(Within the first 2-hour post-treatment interval at Day 1)
- FEV1 AUC4-6 at Day 57(Between 4 hours and 6 hours after drug administration on Day 57)
- Peak FEV1 Response at Day 57(Within the first 2-hour post-treatment interval on Day 57)
- Time to Onset of Therapeutic FEV1 Response at Day 57(Within the first 2-hour post-treatment interval at Day 57)
- Time to Onset of Therapeutic FEV1 Response at Day 85(Within the first 2-hour post-treatment interval at Day 85)
- Duration of Therapeutic FEV1 Response at Day 1(During the 6-hour observation period after drug administration at Day 1)
- Duration of Therapeutic FEV1 Response at Day 29(During the 6-hour observation period after drug administration at Day 29)
- Duration of Therapeutic FEV1 Response at Day 57(During the 6-hour observation period after drug administration at Day 57)
- Duration of Therapeutic FEV1 Response at Day 85(During the 6-hour observation period after drug administration at Day 85)
- Time to Peak FEV1 Response at Day 1(Within the 6-hour post-treatment observation period at Day 1)
- Time to Peak FEV1 Response at Day 29(Within the 6-hour post-treatment observation period at Day 29)
- Peak FEV1 Response at Day 29(Within the first 2-hour post-treatment interval on Day 29)
- Peak FEV1 Response at Day 85(Within the first 2-hour post-treatment interval on Day 85)
- Time to Onset of Therapeutic FEV1 Response at Day 29(Within the first 2-hour post-treatment interval at Day 29)
- Time to Peak FEV1 Response at Day 57(Within the 6-hour post-treatment observation period at Day 57)
- Time to Peak FEV1 Response at Day 85(Within the 6-hour post-treatment observation period at Day 85)
- FVC AUC0-6 at Day 1(Before drug administration to 6 hours after drug administration at Day 1)
- FVC AUC0-6 at Day 29(Before drug administration to 6 hours after drug administration at Day 29)
- FVC AUC0-6 at Day 57(Before drug administration to 6 hours after drug administration on Day 57)
- FVC AUC0-6 at Day 85(Before drug administration to 6 hours after drug administration on Day 85)
- FVC AUC0-4 at Day 1(Before drug administration to 4 hours after drug administration on Day 1)
- FVC AUC0-4 at Day 29(Before drug administration to 4 hours after drug administration on Day 29)
- FVC AUC0-4 at Day 57(Before drug administration to 4 hours after drug administration on Day 57)
- FVC AUC0-4 at Day 85(Before drug administration to 4 hours after drug administration on Day 85)
- FVC AUC4-6 at Day 1(Between 4 hours and 6 hours after drug administration on Day 1)
- FVC AUC4-6 at Day 29(Between 4 hours and 6 hours after drug administration on Day 29)
- FVC AUC4-6 at Day 57(Between 4 hours and 6 hours after drug administration on Day 57)
- FVC AUC4-6 at Day 85(Between 4 hours and 6 hours after drug administration on Day 85)
- Peak FVC Response at Day 1(Within the first 2-hour post-treatment interval at Day 1)
- Peak FVC Response at Day 29(Within the first 2-hour post-treatment interval at Day 29)
- Peak FVC Response at Day 57(Within the first 2-hour post-treatment interval at Day 57)
- Peak FVC Response at Day 85(Within the first 2-hour post-treatment interval at Day 85)
- Rescue Medication Use on Pulmonary Test Day 1(During the 6-hour pulmonary function testing after drug administration on Day 1)
- Rescue Medication Use on Pulmonary Test Day 29(During the 6-hour pulmonary function testing after drug administration on Day 29)
- Rescue Medication Use on Pulmonary Test Day 57(During the 6-hour pulmonary function testing after drug administration on Day 57)
- Rescue Medication Use on Pulmonary Test Day 85(During the 6-hour pulmonary function testing after drug administration on Day 85)
- Night-time Rescue Medication Use(During the 2-week baseline washout period and the 12-week treatment period)
- Daytime Rescue Medication Use(During the 2-week baseline washout period and the 12-week treatment period)
- Night-time Symptom Score(During the 2-week baseline washout period and the 12-week treatment period)
- Daytime Symptom Score(During the 2-week baseline washout period and the 12-week treatment period)
- Trough Peak Expiratory Flow Rate (PEFR)(During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication)
- Physician's Global Evaluation Score on Pulmonary Function Testing Day 29(Prior to pulmonary function test on Day 29)
- Physician's Global Evaluation Score on Pulmonary Function Testing Day 57(Prior to pulmonary function test on Day 57)
- Physician's Global Evaluation Score on Pulmonary Function Testing Day 85(Prior to pulmonary function test on Day 85)
- Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period(During the 12-week on-treatment period)
- COPD Exacerbation Rate During the On-treatment Period(During the 12-week on-treatment period)
- COPD Exacerbation During the On-treatment Period(During the 12-week on-treatment period)
- Frequency Distribution of Satisfaction Rating With Inhaler Attributes(12 weeks)
- Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine(12 weeks)
- Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung(12 weeks)
- Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left(12 weeks)
- Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably(12 weeks)
- Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler(12 weeks)
- Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use(12 weeks)
- Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable(12 weeks)
- Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler(12 weeks)
- Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler(12 weeks)
- Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler(12 weeks)
- Device Preference (Respimat or MDI)(12 weeks)
- Rating of Action of Turning Clear Base of Respimat(12 weeks)
- Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State(Before drug administration to 6 hours after drug administration on Day 29)
- Noncompartmental Parameters of Albuterol at Steady State(Before drug administration to 6 hours after drug administration on Day 29)
- Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours(Before drug administration to 2 hours after drug administration on Day 29)
- Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours(Before drug administration to 2 hours after drug administration on Day 29)
- Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours(Before drug administration to 6 hours after drug administration on Day 26)
- Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours(Before drug administration to 6 hours after drug administration on Day 29)
研究者
研究点 (180)
Loading locations...
相似试验
已完成
4 期
A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)AsthmaNCT00273962Boehringer Ingelheim500
已完成
3 期
Ipratropium Bromide/Salbutamol Delivered by the Respimat® Inhaler Compared to Ipratropium Bromide Respimat®, COMBIVENT® Inhalation Aerosol and Placebo in Adults With Chronic Obstructive Pulmonary DiseasePulmonary Disease, Chronic ObstructiveNCT02177253Boehringer Ingelheim1,118
已完成
2 期
Study of the Comparability of Ipratropium Bromide Hydrofluoroalkane (HFA)-134a Inhalation Aerosol to the Market Standard, Atrovent® Chlorofluorocarbon (CFC) Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary DiseasePulmonary Disease, Chronic ObstructiveNCT02260011Boehringer Ingelheim41
终止
3 期
Efficacy and Safety of Combivent® Aerosol and Spacer, in Adult Patients With Moderate to Severe Asthma CrisisAsthmaNCT02182700Boehringer Ingelheim47
终止
4 期
Study to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, in Acute Asthmatic Attacks in Young ChildrenAsthmaNCT02235428Boehringer Ingelheim3