EUCTR2006-004069-33-BE进行中（未招募）不适用
A randomized, double-blind, double-dummy, active (formoterol 12 µg b.i.d) and placebo controlled, multi-center, 5 period crossover, dose-ranging study to assess the bronchodilatory efficacy and safety of single doses of indacaterol 150 µg, 300 µg and 600 µg delivered via single dose dry powder inhaler (SDDPI) vs. placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
ovartisPharma Services AG0 个研究点目标入组 60 人开始时间: 2006年9月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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 and female adults aged 40-75 years inclusive, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which includes any adjustment to their current COPD treatment).
- •Patients with a clinical diagnosis of COPD according to the GOLD Guidelines (updated July 2005) and a history of characteristic COPD symptoms (such as cough, sputum production, dyspnea), who additionally meet the following criteria:
- •a) Smoking history of at least 10 pack years. (1 pack year is defined as 20 cigarettes per day, every day, for one year, or 10 cigarettes a day for two years, or 40 cigarettes a day for six months etc.).
- •b) FEV1 at Visit 1 and Visit 2 <65% of the predicted normal value and at least 0.75 L. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 h during which no short-acting ?2-agonist has been inhaled, 8 h for short-acting anti-cholinergics, and 48 h for long-acting ?2-agonists.
- •c) Pre-bronchodilator FEV1/FVC at Visit 1 and Visit 2 < 70%
- •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
- •Hospitalization for an exacerbation of COPD, or a respiratory tract infection, in the 6 weeks prior to screening; history of asthma (or history of childhood asthma) or concomitant pulmonary disease; clinically relevant laboratory abnormality or a clinically significant condition; pregnant or nursing (lactating) women, or women of child-bearing potential; long-term oxygen therapy; patients unable to use dry powder inhaler devices or perform spirometry.
- •Treatment for COPD and allied conditions within a specified period prior to screening (or during the study): tiotropium (7 days), long-acting ß2-agonists (48 h), fixed combinations of b2-agonists and inhaled corticosteroids (48 h), theophylline and other Xanthines (1 week), parenteral or oral corticosteroids (1 month).
- •Treatment for COPD and allied conditions for at least the minimum washout period specified, or during the study unless they have been stabilized at least one month prior to start of the study: short-acting ß2-agonists other than albuterol/salbutamol rescue medication (6 h), short-acting anti-cholinergics (8 h), fixed combinations of short-acting ß2-agonists and short-acting anti-cholinergics (8 h).
- •Patients receiving treatment with the following medications unless they have been stabilized at least one month prior to screening: inhaled or nasal corticosteroids, cromoglycate, nedocromil, ketotifen and leukotriene antagonists, some antihistamines (unless they have been stabilized at least 5 days prior to screening).
- •Patients receiving treatment with with non-potassium sparing diuretics, non-selective beta-blocking agents, cardiac anti-arrhythmics Class Ia or Class III, terfenadine, astemizole, mizolastin and any drug with potential to significantly prolong the QT interval, tricyclic antidepressants and monoamino-oxidase inhibitors, antibiotics (if prescribed for a respiratory tract infection).
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