NL-OMON43821已完成4 期
A 26-week, randomized, double blind, parallel-group multicenter study to assess the efficacy and safety of QVA149 (110/50 mcg o.d.) vs tiotropium (18 mcg o.d.) + salmeterol/fluticasone propionate FDC (50/500 mcg b.i.d.) in patients with moderate to severe COPD - NOV741
TFS Trial Form Support BV0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •1. Patients who have signed Informed Consent Form prior to initiation of any study-related
- •2. Male and female adults aged * 40 years.
- •3. Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3)
- •according to the 2014 GOLD Guidelines.
- •4. Patients with a post-bronchodilator FEV1 *40 and < 80% of the predicted normal value,
- •and post-bronchodilator FEV1/FVC < 0.70 at run-in Visit 101.
- •(Post refers to 15 min after inhalation of 400 *g of salbutamol) (Readings assessed by site
- •and checked centrally).
- •5. Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack
- •years <= 1 pack /day x 10 years, or * pack/day x 20 years). An ex-smoker is defined as a
- •patient who has not smoked for * 6 months at screening.
- •6. Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).
排除标准
- •Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No
- •additional exclusions may be applied by the investigator, in order to ensure that the study
- •population will be representative of all eligible patients.
- •1. Use of other investigational drugs/devices (approved or unapproved) at the time of
- •enrollment, or within 30 days or 5 half-lives of Visit 1, whichever is longer.
- •2. Patients contraindicated for treatment with, or having a history of reactions/
- •hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any
- •component thereof:
- •* long and short anticholinergic agents
- •* long and short acting beta-2 agonists
- •* sympathomimetic amines
- •* lactose or any of the other excipients of trial medication
- •3. History or current diagnosis of ECG abnormalities indicating significant risk of safety for
- •patients participating in the study such as:
- •* Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular
- •tachycardia, and clinically significant second or third degree AV block without a
- •* History of familial long QT syndrome or known family history of Torsades de Pointes
- •4. Resting QTc (Fridericia method) *450 msec for males and females at Visit 101.
- •5. Concomitant use of agents known to significantly prolong the QT interval unless it can be
- •permanently discontinued for the duration of study.
- •6. Patients who have a clinically significant laboratory abnormality at Visit 101 and would
- •be at potential risk if enrolled into the study.
- •7. Patients who have clinically significant renal, cardiovascular (such as but not limited to
- •unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial
- •infarction), arrhythmia (see below for patients with atrial fibrillation), neurological,
- •endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological
- •abnormalities which could interfere with the assessment of the efficacy and safety of the
- •study treatment.
- •8. Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with
- •persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months
- •and controlled with a rate control strategy (i.e., beta blocker, calcium channel blocker,
- •pacemaker placement, digoxin or ablation therapy) for at least 6 months may be
- •considered for inclusion. In such patients, atrial fibrillation must be present at Visit 101
- •and Visit 102) visits, with a resting ventricular rate < 100/min. At visit 101, atrial
- •fibrillation must be confirmed by central reading.
- •9. Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or
- •bladder-neck obstruction or moderate to severe renal impairment or urinary retention
- •(BPH patients who are stable on treatment can be considered).
- •10. Patients who have not achieved acceptable spirometry results at Visit 101 in accordance
- •with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for
- •acceptability (one retest may be performed for patients that don*t meet the acceptability
- •11. Patients who have had more than one COPD exacerbation that required treatment with
- •antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1.
- •12. Patients who developed
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