Indacaterol once-daily is equally effective dosed in the evening or morning in COPD

被引:23
作者
Magnussen, H. [2 ]
Verkindre, C. [3 ]
Jack, D. [4 ]
Jadayel, D. [4 ]
Henley, M. [4 ]
Woessner, R. [5 ]
Higgins, M. [4 ]
Kramer, B. [1 ]
机构
[1] Novartis Pharmaceut Inc, E Hanover, NJ 07936 USA
[2] Hosp Grosshansdorf, Pulm Res Inst, D-22927 Grosshansdorf, Germany
[3] Hop Bethune, F-62408 Beuvry, Bethune, France
[4] Novartis Horsham Res Ctr, Horsham RH12 5AB, W Sussex, England
[5] Novartis Pharma AG, CH-4002 Basel, Switzerland
关键词
Chronic obstructive pulmonary disease; Evening dose; Indacaterol; Morning dose; Salmeterol; EFFICACY;
D O I
10.1016/j.rmed.2010.08.010
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
Indacaterol is a novel, inhaled, long acting beta(2) agonist providing 24 h bronchodilation with once daily (o d) dosing in patients with COPD In this double blind, incomplete block crossover study, patients with moderate to severe COPD were randomised to receive three treatment cycles from indacaterol 300 mu g o d dosed PM or AM, salmeterol 50 mu g twice daily or placebo, each for 14 days Trough FEV1 was measured 24 h after indacaterol and 12 h after salmeterol Ninety six patients (mean age 64 years, post bronchodilator FEV1 57% predicted, FEV1/FVC 55%) were randomised, 83 completed After 14 days, the difference vs placebo in trough FEV1 for PM indacaterol was 200 mL (p < 0 001 [primary analysis]) and for AM indacaterol was 200 mL (p < 0 001) Compared with salmeterol, trough FEV1 for PM indacaterol was 110 mL higher (p < 0 001), and for AM indacaterol was 50 mL higher (p = NS) Over 14 days, vs placebo, both PM and AM indacaterol improved the % of nights with no awakenings (by 11 9 and 8 1 points, p < 0 01), the % of days with no daytime symptoms (by 6 7 and 5 5 points, p < 0 05), and the % of days able to perform usual activities (by 6 7 and 7 8 points, p < 0 05) Indacaterol provided 24 h bronchodilation and improvement in symptoms regardless of whether taken regularly in the morning or evening Clinical trial registration ChnicalTrials gov NCT00615030 (C) 2010 Elsevier Ltd All rights reserved
引用
收藏
页码:1869 / 1876
页数:8
相关论文
共 14 条
[1]
[Anonymous], 2008, WORLD HLTH STAT
[2]
[Anonymous], 2016, Fact Sheet
[3]
Safety, tolerability and efficacy of indacaterol, a novel once-daily β2-agonist, in patients with COPD:: A 28-day randomised, placebo controlled clinical trial [J].
Beier, Jutta ;
Chanez, Pascal ;
Martinot, Jean-Benoit ;
Schreurs, A. J. M. ;
Tkacova, Ruzena ;
Bao, Weibin ;
Jack, Damon ;
Higgins, Mark .
PULMONARY PHARMACOLOGY & THERAPEUTICS, 2007, 20 (06) :740-749
[4]
Effect of tiotropium bromide on circadian variation in airflow limitation in chronic obstructive pulmonary disease [J].
Calverley, PMA ;
Lee, A ;
Towse, L ;
van Noord, J ;
Witek, TJ ;
Kelsen, S .
THORAX, 2003, 58 (10) :855-860
[5]
Efficacy of a new once-daily long-acting inhaled β2-agonist indacaterol versus twice-daily formoterol in COPD [J].
Dahl, Ronald ;
Chung, Kian Fan ;
Buhl, Roland ;
Magnussen, Helgo ;
Nonikov, Vladimir ;
Jack, Damon ;
Bleasdale, Patricia ;
Owen, Roger ;
Higgins, Mark ;
Kramer, Benjamin .
THORAX, 2010, 65 (06) :473-479
[6]
Once-Daily Bronchodilators for Chronic Obstructive Pulmonary Disease Indacaterol Versus Tiotropium [J].
Donohue, James F. ;
Fogarty, Charles ;
Lotvall, Jan ;
Mahler, Donald A. ;
Worth, Heinrich ;
Yorgancioglu, Arzu ;
Iqbal, Amir ;
Swales, James ;
Owen, Roger ;
Higgins, Mark ;
Kramer, Benjamin .
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2010, 182 (02) :155-162
[7]
Once-daily indacaterol versus twice-daily salmeterol for COPD: a placebo-controlled comparison [J].
Kornmann, O. ;
Dahl, R. ;
Centanni, S. ;
Dogra, A. ;
Owen, R. ;
Lassen, C. ;
Kramer, B. .
EUROPEAN RESPIRATORY JOURNAL, 2011, 37 (02) :273-279
[8]
Sustained 24-hour efficacy of once daily indacaterol (300 μg) in patients with chronic obstructive pulmonary disease: A randomized, crossover study [J].
LaForce, Craig ;
Aumann, Joseph ;
de Teresa Parreno, Luis ;
Iqbal, Amir ;
Young, David ;
Owen, Roger ;
Higgins, Mark ;
Kramer, Benjamin .
PULMONARY PHARMACOLOGY & THERAPEUTICS, 2011, 24 (01) :162-168
[9]
PASCOE S, 2007, AM J RESP CRIT CARE, V175, pA128
[10]
Rennard SI, 2009, CHEST, V136, p4S