PER-040-10已完成未知
A 52-WEEK TREATMENT, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFECT OF QVA149 (110/50 µg o.d.) vs NVA237 (50 µG O.D.) AND OPEN-LABEL TIOTROPIUM (18 µG O.D.) ON COPD EXACERBATIONS IN PATIENTS WITH SEVER TO VERY CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 31 人开始时间: 2010年7月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40 至 100（—）
- 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 severe to very severe COPD (Stage III or IV) according to the (GOLD Guidelines, 2008).
- •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).
- •Patients with a post-bronchodilator FEV1 < 50% of the predicted normal value, and post-bronchodilator 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).
- •A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics.
排除标准
- •Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
- •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
- •Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia.
- •Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to Visit 1 or between Visit 1 (Day -21) and Visit 3 (Day 1).
- •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.
- •Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 (Day -21)
- •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.
- •Patients with lung lobectomy, or lung volume reduction or lung transplantation.
- •Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition.
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