52-week, Double Blind, Randomized, 2 Active Parallel Arms Study of Fixed Combination CHF 5993 Administered vs Ultibro® in COPD Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,532
- 试验地点
- 1
- 主要终点
- Moderate and severe COPD exacerbation rate over 52 weeks of treatment
研究概览
简要总结
The aim of the present study is to evaluate the superiority of the fixed triple therapy with BDP/FF/GB at a daily dose of 400/24/50 mcg respectively with that of Ultibro® Breezhaler® (DPI), fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg in COPD patients.
详细描述
Outpatients attending the hospital clinics/study centres will be recruited. Patients with severe and very severe COPD airflow obstruction according to GOLD 2014 criteria. A total of approximately 2192 patients will need to be screened in order to obtain 1534 (767 per arm) randomized and evaluable patients. Approximately 200 sites will be involved worldwide.
Each patient will perform a total of 8 clinic visits (V0 to V7) during the study.
The Primary objective is to demonstrate the superiority of CHF 5993 pMDI over Ultibro® in terms of moderate and severe COPD exacerbation rate over 52 weeks of treatment.
The Secondary objectives are:
- To evaluate the effect of CHF 5993 pMDI on other lung function parameters, patient's health status and clinical outcome measures;
- To assess the safety and the tolerability of the study treatments.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CHF 5993 + Ultibro matched placebo
Fixed triple therapy with BDP/FF/GB 100/6/12.5 mcg (CHF 5993) administered 2 puffs twice daily via pMDI + Fixed combination of indacaterol and of glycopyrronium (Ultibro® Breezhaler®) matched placebo administered once daily via DPI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments Saint George's Respiratory Questionnaire EXACT-pro questionnaire
干预措施: CHF 5993 + Ultibro matched placebo (Drug)
CHF 5993 + Ultibro matched placebo
Fixed triple therapy with BDP/FF/GB 100/6/12.5 mcg (CHF 5993) administered 2 puffs twice daily via pMDI + Fixed combination of indacaterol and of glycopyrronium (Ultibro® Breezhaler®) matched placebo administered once daily via DPI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments Saint George's Respiratory Questionnaire EXACT-pro questionnaire
干预措施: Central spirometry (Procedure)
CHF 5993 + Ultibro matched placebo
Fixed triple therapy with BDP/FF/GB 100/6/12.5 mcg (CHF 5993) administered 2 puffs twice daily via pMDI + Fixed combination of indacaterol and of glycopyrronium (Ultibro® Breezhaler®) matched placebo administered once daily via DPI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments Saint George's Respiratory Questionnaire EXACT-pro questionnaire
干预措施: COPD assessment test (Other)
CHF 5993 + Ultibro matched placebo
Fixed triple therapy with BDP/FF/GB 100/6/12.5 mcg (CHF 5993) administered 2 puffs twice daily via pMDI + Fixed combination of indacaterol and of glycopyrronium (Ultibro® Breezhaler®) matched placebo administered once daily via DPI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments Saint George's Respiratory Questionnaire EXACT-pro questionnaire
干预措施: Local laboratory Assessments (Procedure)
CHF 5993 + Ultibro matched placebo
Fixed triple therapy with BDP/FF/GB 100/6/12.5 mcg (CHF 5993) administered 2 puffs twice daily via pMDI + Fixed combination of indacaterol and of glycopyrronium (Ultibro® Breezhaler®) matched placebo administered once daily via DPI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments Saint George's Respiratory Questionnaire EXACT-pro questionnaire
干预措施: Saint George's Respiratory Questionnaire (Other)
CHF 5993 + Ultibro matched placebo
Fixed triple therapy with BDP/FF/GB 100/6/12.5 mcg (CHF 5993) administered 2 puffs twice daily via pMDI + Fixed combination of indacaterol and of glycopyrronium (Ultibro® Breezhaler®) matched placebo administered once daily via DPI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments Saint George's Respiratory Questionnaire EXACT-pro questionnaire
干预措施: EXACT-pro questionnaire (Other)
Ultibro + CHF 5993 matched placebo
Fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg (Ultibro® Breezhaler®) administered once daily via DPI + Fixed triple therapy with BDP/FF/GB (CHF 5993) matched placebo administered 2 puffs twice daily via pMDI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments, Saint George's Respiratory Questionnaire, EXACT-pro questionnaire
干预措施: Ultibro + CHF 5993 matched placebo (Drug)
Ultibro + CHF 5993 matched placebo
Fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg (Ultibro® Breezhaler®) administered once daily via DPI + Fixed triple therapy with BDP/FF/GB (CHF 5993) matched placebo administered 2 puffs twice daily via pMDI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments, Saint George's Respiratory Questionnaire, EXACT-pro questionnaire
干预措施: Central spirometry (Procedure)
Ultibro + CHF 5993 matched placebo
Fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg (Ultibro® Breezhaler®) administered once daily via DPI + Fixed triple therapy with BDP/FF/GB (CHF 5993) matched placebo administered 2 puffs twice daily via pMDI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments, Saint George's Respiratory Questionnaire, EXACT-pro questionnaire
干预措施: COPD assessment test (Other)
Ultibro + CHF 5993 matched placebo
Fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg (Ultibro® Breezhaler®) administered once daily via DPI + Fixed triple therapy with BDP/FF/GB (CHF 5993) matched placebo administered 2 puffs twice daily via pMDI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments, Saint George's Respiratory Questionnaire, EXACT-pro questionnaire
干预措施: Local laboratory Assessments (Procedure)
Ultibro + CHF 5993 matched placebo
Fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg (Ultibro® Breezhaler®) administered once daily via DPI + Fixed triple therapy with BDP/FF/GB (CHF 5993) matched placebo administered 2 puffs twice daily via pMDI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments, Saint George's Respiratory Questionnaire, EXACT-pro questionnaire
干预措施: Saint George's Respiratory Questionnaire (Other)
Ultibro + CHF 5993 matched placebo
Fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg (Ultibro® Breezhaler®) administered once daily via DPI + Fixed triple therapy with BDP/FF/GB (CHF 5993) matched placebo administered 2 puffs twice daily via pMDI for 52-week treatment.
Patient used to take pMDI medication using a spacer will be provided with a new spacer for the study.
7 study visits including : central spirometry tests, Local laboratory, COPD assessment test (visit 1 only), Local laboratory Assessments, Saint George's Respiratory Questionnaire, EXACT-pro questionnaire
干预措施: EXACT-pro questionnaire (Other)
结局指标
主要结局
Moderate and severe COPD exacerbation rate over 52 weeks of treatment
时间窗: 1 year
Exacerbations will be evaluated at each study visit and collected using EXACT-PRO filled-in by patient every day throughout the study
次要结局
- Time to first moderate to severe COPD exacerbation(1 year)
- Rate of moderate COPD exacerbation over 52 weeks of treatment(1 year)
- Rate of severe COPD exacerbation over 52 weeks of treatment(1 year)
- Change from Baseline at each visit and over the entire treatment period in pre-dose morning FEV1(1 year)