Abstract
Indacaterol has a 24 h bronchodilatory effect, which allows the drug to be effective with once-daily administration. The speed of onset of bronchodilation after inhalation of indacaterol is as fast as that seen for salbutamol and formoterol. Compared to placebo, significant improvements are seen 5 min after dosing.
Patients with COPD who received indacaterol 150 μg or 300 μg once daily in large (n > 400), randomized, double-blind, placebo-controlled, multicenter phase 3 trials had a significantly higher mean trough FEV1 compared to placebo after 12 weeks treatment. The absolute differences in trough FEV1 between indacaterol and placebo were 130–180 ml and exceeded the predetermined clinically relevant threshold of 120 ml in all trials.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Feldman G, Siler T, Prasad N, Jack D, Piggott S, Owen R, Higgins M, Kramer B (2010) The INLIGHT 1 study group. Efficacy and safety of indacaterol 150 μg once-daily in COPD: a double-blind, randomised,12-week study. BMC Pulm Med 10:11. doi:10.1186/1471-2466-10-11
Donohue JF, Fogarty C, Lötvall J, Mahler DA, Worth H, Yorgancioglu A, Iqbal A, Swales J, Owen R, Higgins M, Kramer B, INHANCE study investigators (2010) Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med 182:155–62
Kornmann O, Dahl R, Centanni S, Dogra A, Owen R, Lassen C, Kramer B, INLIGHT 2 study investigators (2011) Once-daily indacaterol vs twice-daily salmeterol for COPD: a placebo-controlled comparison. Eur Respir J 37:273–279
Dahl R, Chung K, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B, INVOLVE study investigators (2010) Efficacy of a new once-daily LABA, indacaterol, versus the twice-daily LABA formoterol, in COPD. Thorax 65:473–479
Chapman KR, Rennard SI, Dogra A, Owen R, Lassen C, Kramer B, INDORSE Study (2011) COPD: a randomized, placebo-controlled a long-acting beta2-agonist, in subjects with long-term safety and efficacy of indacaterol. Chest 140:68–75
Buhl R, Dunn LJ, Disdier C, Lassen C, Amos C, Henley M, Kramer B, INTENSITY study investigators (2011) Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J 38:797–803
Vogelmeier K, Ramos-Barbon D, Jack D, Piggott S, Owen R, Higgins M, Kramer B, INTIME study investigators (2010) Indacaterol provides 24-hour bronchodilation in COPD: a placebo-controlled blinded comparison with tiotropium. Respir Res 11:135
Korn S, Kerwin E, Atis S, Amos C, Owen R, Lassen C, INSIST study group (2011) Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: A 12-week study. Respir Med 105:719–726
Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: revised 2011. Available from: http://www.goldcopd.org/uploads/users/files/GOLD_Report_2011_Jan21.pdf
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P et al (2005) ATS/ERS task force. Standardisation of spirometry. Eur Respir J 26:319–338
Donohue JF (2005) Minimal clinically important differences in COPD lung function. COPD 2:111–124
Westwood M, Bourbeau J, Jones PW, Cerulli A, Capkun-Niggli G, Worthy G (2011) Relationship between FEV1 change and patient reported outcomes in randomised trials of inhaled bronchodilators for stable COPD: a systematic review. Respir Res 12:40
Cazzola M, MacNee W, Martinez FJ, Rabe KF, Franciosi LG, Barnes PJ, Brusasco V, Burge PS, Calverley PM, Celli BR, Jones PW, Mahler DA, Make B, Miravitlles M, Page CP, Palange P, Parr D, Pistolesi M, Rennard SI, Rutten-van Molken MP, Stockley R, Sullivan SD, Wedzicha JA, Wouters EF (2008) Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J 31:416–469
Barnes PJ, Pocock SJ, Magnussen H, Iqbal A, Kramer B, Higgins M, Lawrence D (2010) Integrating indacaterol dose selection in a clinical study in COPD using an adaptive seamless design. Pulm Pharmacol Ther 23:165–171
Buhl R, Mahler DA, Owen R, Lassen C, Kramer B (2010) Indacaterol provides effective bronchodilation in patients with COPD irrespective of age. Abstract 1190 ERS annual congress
Decramer M, Donohue J, Owen R, Lassen C, Kramer B (2010) Indacaterol provides effective bronchodilation in patients with COPD regardless of inhaled corticosteroid use. Abstract 5555 ERS annual congress
Kleerup EC, D’Urzo A, Owen R, Lassen C, Kramer B (2010) Once-daily indacaterol provides significant bronchodilation in chronic obstructive pulmonary disease patients irrespective of baseline reversibility. Am J Respir Crit Care Med 181:A4439
Renard D, Looby M, Kramer B, Lawrence D, Morris D, Stanski DR (2011) Characterization of the bronchodilatory dose response to indacaterol in patients with chronic obstructive pulmonary disease using model based approaches. Respir Res 12:54
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer Basel
About this chapter
Cite this chapter
Dahl, R. (2014). Phase 3 Clinical Efficacy Studies: Lung Function. In: Trifilieff, A. (eds) Indacaterol. Milestones in Drug Therapy. Springer, Basel. https://doi.org/10.1007/978-3-0348-0709-8_6
Download citation
DOI: https://doi.org/10.1007/978-3-0348-0709-8_6
Published:
Publisher Name: Springer, Basel
Print ISBN: 978-3-0348-0708-1
Online ISBN: 978-3-0348-0709-8
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)