EUCTR2008-000901-13-SK进行中（未招募）1 期
A randomized, multi-center, double-blind, double-dummy, parallel-group, 8 week pilot study, to investigate the effect of QMF Twisthaler® (250/400 µg q.d. evening) compared to fluticasone propionate/salmeterol (250/50 µg b.i.d.) FSC in patients with Chronic Obstructive Pulmonary Disease (COPD).
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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 adult patients aged > 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to COPD medication prior to Visit 1.
- •Patients with a diagnosis of moderate to severe COPD as classified by the GOLD guidelines (2006) and who additionally meet the following criteria:
- •a) Ex-smoker or current smoker with a smoking history of at least 10 pack years.
- •NOTE: Current smokers must provide verbal notification or written documentation that attests to their inability to stop smoking after participation (or declining to participate) in a smoking cessation program. Ex-smokers are defined as those who have stopped smoking at least 12 months prior to Visit 1.
- •b) Post-bronchodilator FEV1 at Visit 1 between 30 and 65% of the predicted normal value [Quanjer et al. 1994]. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hr during which no short acting ?2-agonist has been inhaled, 8 hr for short acting anti-cholinergic, or FDC of inhaled anticholinergic/SABA, and 48 hr for ICS, long-acting ß2-agonists or FDC of ICS/ß2 agonist
- •c) Post-bronchodilator FEV1/FVC < 70%
- •d) TLC or FRC of 120% of the predicted normal value for those patients undergoing the body plethysmography assessments.
- •(Post-bronchodilator refers to measurements approximately 30 minutes after inhalation of 4 inhalations of 100/90 µg of salbutamol/albuterol MDI or equivalent dose of DPI)
- •Patients must be on only short acting ß2 agonist for relief for at least 7 days prior to randomization (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, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
- •Patients with COPD exacerbation within 4 weeks prior to randomization which requires medical intervention or treatment with additional excluded medication.
- •Patients demonstrating an increase in FEV1 = 400 mL 30 minutes after administration of four inhalations of 100/90 µg salbutamol/albuterol at the screening visit.
- •Patients requiring oxygen therapy (>15 hr a day) for chronic hypoxemia (`prn’ use up to 10 hr total in any given 24 hr period is acceptable).
- •Patient with an acute respiratory tract infection within 4 weeks prior to Visit 1. Patients who develop a respiratory tract infection between Visit 1 and visit 2 must discontinue from the trial, but may be permitted to re-screen at a later date (at least 4 weeks after the resolution of the respiratory tract infection).
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