EUCTR2012-005102-22-CZ进行中（未招募）1 期
A 12-week treatment, multi-center, randomized, double-blind, double-dummy, parallel-group study to assess the efficacy, safety and tolerability of QVA149 compared to fluticasone/salmeterol in COPD patients with moderate to severe airflow limitation
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 555
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. Patients who have signed an Informed Consent Form prior to initiation of any studyrelated
- •2. Male and female adults aged =40 years.
- •3. Patients with stable COPD according to the current GOLD strategy (GOLD 2011).
- •4. Patients with airflow limitation indicated by a post-bronchodilator FEV1 = 30% and <80%
- •of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at run-in (Visit 101).
- •Post-bronchodilator refers to 1 hour after sequential inhalation of 84 µg ipratropium
- •bromide (or equivalent dose) and 400 µg salbutamol (or 360 µg albuterol). Spacer devices
- •are not permitted during reversibility testing.
- •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 ½ pack/day x 20 years). An ex-smoker may be defined
- •as a subject who has not smoked for = 6 months at screening.
- •6. Patients with an mMRC grade 2 or greater at Visit 101
- •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 289
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 266
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
- •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 laboratory. These patients should not be re-screened.
- •For more exclusion criteria, please refer to the protocol
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