EUCTR2009-013504-32-NL进行中（未招募）不适用
A 26-week treatment, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety and tolerability of NVA237 in patients with chronic obstructive pulmonary disease.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
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 moderate to severe stable COPD (Stage II or Stage III) according to the (GOLD Guidelines 2008).
- •3. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- •4. Patients with a post-bronchodilator FEV1 =30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (day -14)
- •5. Patients, according to daily electronic diary data between Visit 2 (-14) and Visit 3 (day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3 (For scoring information see Section 7.4.3.1.)
- •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 test).
- •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 months of spontaneous amenorrhea with serum FSH levels >40 mIU/ml, OR have past 6 weeks from 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),
- •double barrier method (diaphragm plus condom)
- •hormonal contraception (implantable, patch, oral, IM), and copper coated IUD), if accepted by local regulatory authority and ethics committee.
- •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; if accepted by local regulatory authority and ethics committee.
- •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 hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 (day -21) and Visit 3 (day 1).
- •4. Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1 (day -21). Patients who develop a lower respiratory tract infection or COPD exacerbation during the screening period (up to Visit 3 (day 1)) will not be eligible, but will be permitted to be re-screened at a later date (at least 6 weeks after the resolution of the lower respiratory tract infection).
- •5. Patients who, in the judgment of the investigator or the responsible Novartis personnel, 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.
- •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
- •6. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at visit 1) or onset of symptoms prior to age 40 years.
- •7. Patients with known history and diagnosis of ?-1 antitrypsin deficiency
- •8. Patients involved in the active phase of a supervised pulmonary rehabilitation programme
- •9. Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by x-ray to be no longer active) or clinically significant bronchiectasis
- •10. Patients with allergic r
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