EUCTR2012-004966-16-CZ进行中（未招募）1 期
A 52-week treatment, multi-center, randomized, double-blind, double-dummy, parallel-group, active controlled study to compare the effect of QVA149 (indacaterol maleate / glycopyrronium bromide) with salmeterol/fluticasone on the rate of exacerbations in subjects with moderate to very severe COPD.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,332
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Male or female adults aged =40 years.
- •3. Patients with stable COPD according to the current GOLD strategy (GOLD 2011).
- •4. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten packyears
- •are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
- •5. Patients with a post-bronchodilator FEV1 =25 and < 60% of the predicted normal value,
- •and post-bronchodilator FEV1/FVC < 0.70 at Visit 101 (day -28).
- •(Post refers to 1 h after sequential inhalation of 84 µg (or equivalent dose) of ipratropium
- •bromide and 400 µg of salbutamol).
- •6. A documented history of at least 1 COPD exacerbation in the previous 12 months that
- •required treatment with systemic glucocorticosteroids and/or antibiotics.
- •7. Patients taking stable COPD medication (at least 60 days) prior to Visit 101.
- •8. Patients with an mMRC grade of at least 2 at Visit 101 (day -28).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1532
排除标准
- •1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
- •female after conception and until the termination of gestation, confirmed by a positive
- •hCG (human Chorionic Gonadotropin) laboratory test.
- •2. Women of child-bearing potential, defined as all women physiologically capable of
- •becoming pregnant, unless they are using effective methods of contraception during
- •dosing of study treatment. Effective contraception methods include:
- •Total abstinence when this is in line with the preferred and usual lifestyle of the
- •subject (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
- •methods) and withdrawal are not acceptable methods of contraception).
- •Female sterilization defined as surgical hysterectomy, bilateral oophorectomy, or
- •tubal ligation at least six weeks before taking the study treatment (Single
- •oophorectomy does not meet the definition of female sterilization).
- •Male sterilization (at least 6 months prior to screening). For female subjects on the
- •study, the vasectomized male partner should be the sole partner for that subject.
- •Barrier methods of contraception: condom or occlusive cap (diaphragm or
- •cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
- •Use of oral, injected or implanted hormonal methods of contraception or other forms
- •of hormonal contraception that have comparable efficacy (failure rate <1%), for
- •example hormone vaginal ring or transdermal hormone contraception. In case of use
- •of oral contraception women should have been stable on the same pill for a minimum
- •of 3 months before taking study treatment.
- •Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •Women are considered post-menopausal and not of child bearing potential if they have
- •had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical
- •profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical
- •bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six
- •weeks ago. In the case of oophorectomy alone, only when the reproductive status of
- •the woman has been confirmed by follow up hormone level assessment is she
- •considered not of child bearing potential.
- •3. Patients with Type I or uncontrolled Type II diabetes.
- •4. Patients with a history of long QT syndrome or whose QTc measured at Visit 101
- •(Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a
- •central assessor. These patients should not be re-screened.
- •5. Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 201.
- •(These patients should not be re-screened)
- •6. Patients who have a clinically significant laboratory abnormality at Visit 101.
- •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., selective bet
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