EUCTR2008-008394-63-DE进行中（未招募）不适用
A 52-week treatment, randomized, double-blind, placebo-controlled, with open label tiotropium, parallel-group study to assess the efficacy, safety and tolerability of NVA237 in patients with chronic obstructive pulmonary disease
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
- 1,065
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
- •2. Women of child-bearing potential, as defined in the protocol
- •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 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 contraindicated for tiotropium or ipatropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents.
- •8. Patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
- •9. Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (day -21) (Fridericia method) is prolonged (>450 ms for males or >470 for females).
- •10. Treatments for COPD and allied conditions: the following medications should not be used between Visits 1 (day -21) and 3 (day 1).
- •The minimum washout prior to Visit 2 (Day -14) is specified below. For patients in the Holter monitor sub-group minimum washout is prior to the day before Visit 2 (day -15):
- •The long acting anticholinergic agent tiotropium:7 days.
- •Short acting anticholinergics: 8 h
- •Fixed combinations of ß2-agonists and inhaled corticosteroids: 48 hours. (Patients taking fixed combinations of ß2-agonists and inhaled corticosteroids must be switched to the equivalent inhaled corticosteroid as monotherapy plus salbutamol/albuterol as rescue therapy at least 48 hours prior to Visit 2)
- •Long-acting ß2-agonists: 48 h
- •Short acting ß2-agonists (other than those prescribed in the study): 6 h
- •Theophylline (any formulation): 7 days
- •Combinations of inhaled short acting anticholinergics and short acting ß2-agonists: 12 hours
- •11. Patients who need the following treatments for COPD and allied conditions unless they have been stabilized as follows:
- •Inhaled corticosteroids, in recommended and constant doses and dose regimens (previously given as part of a fixed dose combination of LABA + ICS) – at least one month prior to Visit 1.
- •Intranasal
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