tailieunhanh - Báo cáo y học: " Indacaterol provides 24-hour bronchodilation in COPD: a placebo-controlled blinded comparison with tiotropium"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học 'Respiratory Research cung cấp cho các bạn kiến thức về ngành y đề tài:Indacaterol provides 24-hour bronchodilation in COPD: a placebo-controlled blinded comparison with tiotropium. | Vogelmeier et al. Respiratory Research 2010 11 135 http content 11 1 135 RESPIRATORY RESEARCH RESEARCH Open Access Indacaterol provides 24-hour bronchodilation in COPD a placebo-controlled blinded comparison with tiotropium Claus Vogelmeier1 David Ramos-Barbon2 Damon Jack3 Simon Piggott3 Roger Owen3 Mark Higgins3 Benjamin Kramer4 INTIME study investigators INdacaterol TIotropium Measuring Efficacy Abstract Background Indacaterol is a novel inhaled once-daily ultra-long-acting p2-agonist for the treatment of chronic obstructive pulmonary disease COPD . This randomized double-blind study compared the bronchodilator efficacy of indacaterol with that of placebo and tiotropium in patients with moderate-to-severe COPD. Methods In an incomplete-block multi-dose three-period crossover design patients received three of the following four treatments indacaterol 150 pg indacaterol 300 pg tiotropium 18 pg and placebo each once-daily for 14 days. Each treatment period was separated by a 14-day washout. Study drug was supplied daily by blinded third party study personnel to maintain blinding of patients and investigators. The primary efficacy variable was trough forced expiratory volume in one second FEV1 at 24 h post-dose after 14 days. The study was powered to demonstrate non-inferiority of indacaterol to tiotropium for this variable. Results A total of 169 patients were randomized mean age 65 years 153 completed. Trough FEV1 after 14 days with indacaterol 150 pg and 300 pg was statistically and clinically superior to placebo with differences 95 CI of 170 120-220 and 150 100-200 mL respectively both p . For this endpoint both doses of indacaterol not only met the criterion for non-inferiority compared with tiotropium but also achieved numerically higher values with differences versus tiotropium of 40 and 30 mL for indacaterol 150 and 300 pg respectively. At 5 min post-dose on Day 1 the mean FEV1 for both indacaterol doses was significantly .

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