EUCTR2007-000642-13-FR进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, 4 period incomplete block cross-over, multi-center, multiple dose (7 days) dose-ranging study to assess the efficacy and safety of 4 doses of NVA237 in patients with stable Chronic Obstructive Pulmonary Disease (COPD), compared to seven days treatment with tiotropium (18µg once daily, open label) as an active control.
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
- 73
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
- •Male or female adults aged = 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- •Patients with moderate to severe COPD according to the GOLD Guidelines (2006).
- •Patients who have smoking history of at least 10 pack years.
- •Patients with a post-bronchodilator FEV1 =30 % and < 80 % of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2.
- •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
- •Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test) and females of childbearing potential who do not use a reliable contraceptive method.
- •Patients requiring oxygen therapy 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 during the run-in period (between Visit 1 and Visit 3).
- •Patients who have had respiratory tract infection within 6 weeks prior to Visit 1.
- •Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
- •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, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.
- •Patients with a history of asthma indicated by (but not limited to):
- •a) Blood eosinophil count > 400/mm3
- •b) Onset of symptoms prior to age 40 years.
- •Patients contraindicated for tiotropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents.
- •Patients with a history of long QT syndrome or whose QTc measured at Visit 1 is prolonged (>440 ms for males or >460 for females).
- •Patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
- •Treatments for COPD and allied conditions : the following medications should not be used between Visits 1 and 18. The minimum washout prior to Visit 2 is specified below :
- •The long acting anticholinergic agent tiotropium :7 days.
- •Short acting anticholinergics : 8 h
- •Fixed combinations of beta 2-agonists and inhaled corticosteroids : 48 h - Patients taking fixed combinations of corticosteroid/beta-agonist prior to Visit 1 should be transferred to the same dose of steroid contained in the fixed combination and on-demand rescue medication for a period of 2 weeks prior to Visit 2.
- •Long-acting beta 2-agonists : 48 h
- •Short acting beta 2-agonists (other than those prescribed in the study): 6 hours
- •Theophylline (any formulation): 7 days
- •Combinations of inhaled anticholinergics and beta agonists: 24 hours
- •Patients taking fixed combinations of corticosteroid/beta-agonist prior to Visit 1 should be transferred to the same dose of steroid contained in the fixed combination and on-demand rescue medication for a period of 2 weeks prior to Visit 2.
- •Patients who need the following treatments for COPD and allied conditions unless they have been stabilized for at least one month prior to visit 1 :
- •Inhaled or nasal corticosteroids
- •Cromoglycate, nedocromil, ketotifen in recommended and constant doses and dose regimens
- •Patients taking beta blocking agents
- •Patients unable to use a dry powder inhaler (Single Dose Dry Powder Inhaler or HandiHaler® type) device or a pMDI (rescue medication), perform spirometry measurements or complete a patient log.
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of Visit 1, whichever is longer.
- •History of hypersensitivity to any of the st
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