Safety and Efficacy of NVA237 as an add-on to Fixed Dose Combination LABA/ICS (GLOW8)
2017年4月19日 更新者:Novartis Pharmaceuticals
A 26-week Multi-center Randomized Double-blind Study to Compare Efficacy and Safety of NVA237 Versus Placebo as an add-on to Maintenance Therapy With Fixed-dose Combination Salmeterol/Fluticasone Propionate in COPD Patients With Moderate to Severe Airflow Limitation
This study is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.) via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status and is well tolerated compared to placebo in symptomatic COPD patients with moderate to severe airflow limitation who are already receiving maintenance therapy with inhaled fixed-dose-combination of salmeterol/fluticasone propionate (50/500 µg) twice daily (b.i.d.) via multi-dose dry powder inhaler (MDDPI).
研究概览
研究类型
介入性
阶段
- 第三阶段
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
40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:
- Current or ex-smokers who have a smoking history of at least 10 pack years (e.g., 10 pack years = 1 pack/day × 10 years, ½ pack/day × 20 years, etc.).
- COPD (Chronic Obstructive Pulmonary Disease) patients with moderate to severe airflow limitation (Spirometry classification: GOLD 2 or 3) at Visit 2:
- Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) ≥30% and <60% of the predicted normal, and,
- Post-bronchodilator FEV1/forced vital capacity (FVC) <0.70
- Patients on maintenance treatment with fixed-dose combination of inhaled salmeterol and fluticasone propionate (50/500 µg) b.i.d. delivered via a proprietary MDDPI (multidose dry powder inhaler) device for at least 30 days prior to screening visit (Visit 1).
- Patients in category Gold B or D with a CAT (COPD Assessment Test) total score ≥10 at screening (Visit 1) and before randomization (Visit 3).
- Patients with a history of at least 1 moderate or severe COPD exacerbation within the previous year.
Exclusion Criteria:
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using effective methods of contraception during the study
- Patients with a history of long QT syndrome or whose QTc measured at run-in (Visit 2) (Fridericia method) is prolonged (>450 ms). (These patients cannot be re-screened.)
- Patients with evidence (upon visual inspection) of oropharyngeal candidiasis at baseline with or without treatment.
- Patients who have not achieved an acceptable spirometry result at run-in (Visit 2) in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability and repeatability.
- Patients who have had a COPD exacerbation that required treatment with antibiotics or oral corticosteroids or hospitalization in the 6 weeks prior to screening (Visit 1).
- Patients who have had a respiratory tract infection within 4 weeks prior to screening (Visit 1).
- Patients requiring long term oxygen therapy prescribed for >12 hours per day.
- Patients with allergic rhinitis who use an H1 antagonist or intra-nasal corticosteroids intermittently. (Treatment with a stable dose or regimen is permitted.)
- Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, or pulmonary hypertension), clinically significant bronchiectasis, or history of pulmonary lobectomy, lung volume reduction surgery, or lung transplantation.
- Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active.
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:Placebo
Placebo to NVA237 (50 μg) o.d. in the morning Patients will also receive open label salmeterol/fluticasone propionate (50/500 µg) b.i.d., in the morning and evening
|
Placebo to NVA237
|
实验性的:NVA237
NVA237 (50 μg) o.d. in the morning Patients will also receive open label salmeterol/fluticasone propionate (50/500 µg) b.i.d., in the morning and evening.
|
NVA237 (50µg, o.d.
via SDDPI) in the morning,
|
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 1 second (FEV1)
大体时间:after 12 weeks of treatment
|
Comparison of NVA237 treatment versus placebo treatment in the trough FEV1 after 12 weeks of treatment
|
after 12 weeks of treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Total score of St George's Respiratory Questionnaire for COPD patients (SGRQ-C).
大体时间:26 weeks
|
Comparison of NVA237 treatment versus placebo treatment in terms of change in SGRQ-C after 26 weeks of treatment
|
26 weeks
|
Trough Forced Expiratory Volume in 1 second (FEV1)
大体时间:week 4 , week 26
|
Comparison of effect of NVA237 treatment versus placebo treatment in FEV1 after 4 weeks and after 26 weeks of treatment
|
week 4 , week 26
|
Total score of the Transition Dyspnea Index (TDI)
大体时间:Week 12 and week 26
|
Comparison of effect of NVA237 treatment versus placebo treatment in the total TDI score after 12 weeks and after 26 weeks of treatment
|
Week 12 and week 26
|
Assessment of safety and tolerability
大体时间:26 Weeks
|
All safety endpoints will be summarized for the safety set.
|
26 Weeks
|
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。
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
2013年4月1日
初级完成 (预期的)
2014年4月1日
研究完成 (预期的)
2014年4月1日
研究注册日期
首次提交
2012年12月17日
首先提交符合 QC 标准的
2012年12月20日
首次发布 (估计)
2012年12月28日
研究记录更新
最后更新发布 (实际的)
2017年4月20日
上次提交的符合 QC 标准的更新
2017年4月19日
最后验证
2013年8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
- CNVA237A2311
- 2012-002854-21
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.
Placebo to NVA237的临床试验
-
Sumitomo Pharma Co., Ltd.完全的
-
Novartis Pharmaceuticals完全的
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