EUCTR2009-013256-69-NL进行中（未招募）不适用
A 52-week treatment, multi-center, randomized, double-blind,parallel-group, active controlled study to evaluate the effect ofQVA149 (110/50 µg o.d.) vs NVA237 (50 µg o.d.) and open-labeltiotropium (18 µg o.d.) on COPD exacerbations in patients withsevere to very severe chronic obstructive pulmonary disease(COPD)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,200
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. Male or female adults aged =40 years, who have signed an Informed Consent Form prior
- •to initiation of any study-related procedure.
- •2. Patients with severe to very severe COPD (Stage III or IV) according to the (GOLD
- •Guidelines, 2008).
- •3. 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).
- •4. Patients with a post-bronchodilator FEV1 < 50% of the predicted normal value, and postbronchodilator
- •FEV1/FVC < 0.70 at Visit 2 (day -14).
- •(Post refers to 1 h after sequential inhalation of 84 µg (or equivalent dose) of ipratropium
- •bromide and 400 µg of salbutamol).
- •5. A documented history of at least 1 COPD exacerbation in the previous 12 months that
- •required treatment with systemic glucocorticosteroids and/or antibiotics.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy
- •2. Women of child-bearing potential (WOCBP), defined as all women physiologically
- •capable of becoming pregnant, including women whose career, lifestyle, or sexual
- •orientation precludes intercourse with a male partner and women whose partners have
- •been sterilized by vasectomy or other means, UNLESS they meet the following definition
- •of post-menopausal: 12 months of natural (spontaneous) amenorrhea, OR 6 weeks after
- •surgical bilateral oophorectomy (with or without hysterectomy) OR are using one or more
- •of the following acceptable methods of contraception:
- •surgical sterilization (e.g. bilateral tubal ligation)
- •hormonal contraception (implantable, patch, oral, IM), and copper coated IUD (if
- •accepted by local regulatory authority and ethics committee)
- •double barrier method (diaphragm plus condom)
- •At the discretion of the investigator, total abstinence is acceptable in cases where the
- •age, career, lifestyle, or sexual orientation of the patient ensures compliance
- •Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
- •methods) and withdrawal are not acceptable methods of contraception. NOTE:
- •Reliable contraception should be maintained throughout the study.
- •3. Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic
- •4. Patients who have had a COPD exacerbation that required treatment with antibiotics, oral
- •steroids or hospitalization in the 6 weeks prior to Visit 1 or between Visit 1 (Day -21) and
- •Visit 3 (Day 1).
- •5. Patients who develop a COPD exacerbation during a period between Visit 1 and 3 will not
- •be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the
- •resolution of the COPD exacerbation.
- •6. Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 (Day -
- •Patients who develop an upper or lower respiratory tract infection during the
- •screening period (up to Visit 3 (Day 1) will not be eligible, but will be permitted to be
- •re-screened 4 weeks after the resolution of the respiratory tract infection
- •7. Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless
- •confirmed by chest x-ray to be no longer active), clinically significant bronchiectasis,
- •sarcoidosis, interstitial lung disorder or pulmonary hypertension.
- •8. Patients with lung lobectomy, or lung volume reduction or lung transplantation.
- •9. Patients who, in the judgment of the investigator, have a clinically relevant laboratory
- •abnormality or a clinically significant condition such as (but not limited to):
- •unstable ischemic heart disease, left ventricular failure, history of myocardial
- •infarction, arrhythmia (excluding chronic stable AF)
- •history of malignancy of any organ system (including lung cancer), treated or
- •untreated, within the past 5 years whether or not there is evidence of local recurrence
- •or metastases, with the exception of localized basal cell carcinoma of the skin
- •uncontrolled hypo- or hyperthyroidism, hypokalemia or hyperadrenergic state
- •narrow-angle glaucoma
- •symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe
- •renal impairment or urinary retention
- •any condition which might compromise patient safety or compliance, interfere with
- •evaluation, or preclude completion of the study
- •10. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil
- •count > 60
研究者
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