Characterization of the bronchodilatory dose response to indacaterol in patients with chronic obstructive pulmonary disease using model-based approaches

Respiratory Research

Volumn 12, Issue , 2011, Pages

  Renard, Didier ^a   Looby, Michael ^a   Kramer, Benjamin ^a   Lawrence, David ^b   Morris, David ^a   Stanski, Donald R ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b NOVARTIS HORSHAM RESEARCH CENTRE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

FORMOTEROL; INDACATEROL; PLACEBO; SALMETEROL; TIOTROPIUM BROMIDE; 5 (2 (5,6 DIETHYLINDAN 2 YLAMINO) 1 HYDROXYETHYL) 8 HYDROXY 1H QUINOLIN 2 ONE; 5-(2-(5,6-DIETHYLINDAN-2-YLAMINO)-1-HYDROXYETHYL)-8-HYDROXY-1H-QUINOLIN-2-ONE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BRONCHODILATING AGENT; INDAN DERIVATIVE; QUINOLONE DERIVATIVE;

ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; DOSE RESPONSE; DRUG EFFICACY; FORCED EXPIRATORY VOLUME; HUMAN; MAXIMUM PERMISSIBLE DOSE; META ANALYSIS; NONLINEAR MIXED EFFECT; NONLINEAR SYSTEM; CONTROLLED CLINICAL TRIAL (TOPIC); DECISION SUPPORT SYSTEM; DOSE CALCULATION; DRUG EFFECT; HOSPITALIZATION; LUNG; PATHOPHYSIOLOGY; TIME; TREATMENT OUTCOME;

ADRENERGIC BETA-2 RECEPTOR AGONISTS; BRONCHODILATOR AGENTS; CONTROLLED CLINICAL TRIALS AS TOPIC; DECISION SUPPORT TECHNIQUES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DOSAGE CALCULATIONS; FORCED EXPIRATORY VOLUME; HUMANS; INDANS; LUNG; NONLINEAR DYNAMICS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUINOLONES; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 79955098782     PISSN: 14659921     EISSN: 1465993X     Source Type: Journal    
DOI: 10.1186/1465-9921-12-54     Document Type: Article

References (23)

1. Dahl R, Chung KF, Buhl R, Magnussen H, Nonikov V, Jack D, Bleasdale P, Owen R, Higgins M, Kramer B. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax 2010, 65:473-479. 10.1136/thx.2009.125435, 20522841.
2. Donohue JF, Fogarty C, Lotvall J, Mahler DA, Worth H, Yorgancioglu A, Iqbal A, Swales J, Owen R, Higgins M, Kramer B. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med 2010, 182:155-162. 10.1164/rccm.200910-1500OC, 20463178.
3. Feldman G, Siler T, Prasad N, Jack D, Piggott S, Owen R, Higgins M, Kramer B. Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double-blind, randomised, 12-week study. BMC Pulm Med 2010, 10:11. 10.1186/1471-2466-10-11, 2848004, 20211002.
4. Kornmann O, Dahl R, Centanni S, Dogra A, Owen R, Lassen C, Kramer B. Once-daily indacaterol vs twice-daily salmeterol for COPD: a placebo-controlled comparison. Eur Respir J 2010, 37:273-279.
5. Barnes PJ, Pocock SJ, Magnussen H, Iqbal A, Kramer B, Higgins M, Lawrence D. Integrating indacaterol dose selection in a clinical study in COPD using an adaptive seamless design. Pulm Pharmacol Ther 2010, 23:165-171. 10.1016/j.pupt.2010.01.003, 20080201.
6. Rennard SI, Chapman KR, Luthra A, Swales J, Lassen C, Owen R, Kramer B. Once-daily indacaterol provides effective bronchodilation over 1 year of treatment in patients with chronic obstructive pulmonary disease (COPD). Chest 2009, 136:4S.
7. Bornkamp B, Bretz F, Dmitrienko A, Enas G, Gaydos B, Hsu CH, Konig F, Krams M, Liu Q, Neuenschwander B, Parke T, Pinheiro J, Roy A, Sax R, Shen F. Innovative approaches for designing and analyzing adaptive dose-ranging trials. J Biopharm Stat 2007, 17:965-995. 10.1080/10543400701643848, 18027208.
8. Aalbers R, Ayres J, Backer V, Decramer M, Lier PA, Magyar P, Malolepszy J, Ruffin R, Sybrecht GW. Formoterol in patients with chronic obstructive pulmonary disease: a randomized, controlled, 3-month trial. Eur Respir J 2002, 19:936-943. 10.1183/09031936.02.00240902, 12030736.
9. Cazzola M, Matera MG, Santangelo G, Vinciguerra A, Rossi F, D'Amato G. Salmeterol and formoterol in partially reversible severe chronic obstructive pulmonary disease: a dose-response study. Respir Med 1995, 89:357-362. 10.1016/0954-6111(95)90008-X, 7638371.
10. Ikeda A, Nishimura K, Koyama H, Izumi T. Comparative dose-response study of three anticholinergic agents and fenoterol using a metered dose inhaler in patients with chronic obstructive pulmonary disease. Thorax 1995, 50:62-66. 10.1136/thx.50.1.62, 473711, 7886652.
11. Littner MR, Ilowite JS, Tashkin DP, Friedman M, Serby CW, Menjoge SS, Witek TJ. Long-acting bronchodilation with once-daily dosing of tiotropium (Spiriva) in stable chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2000, 161:1136-1142.
12. Whale CI, Sovani MP, Mortimer KJ, Harrison TW, Tattersfield AE. Systemic and bronchodilator effects of inhaled rac-formoterol in subjects with chronic obstructive pulmonary disease: a dose-response study. Br J Clin Pharmacol 2008, 65:841-847. 10.1111/j.1365-2125.2007.03081.x, 2485218, 18394012.
13. Bauwens O, Ninane V, Van de Maele B, Firth R, Dong F, Owen R, Higgins M. 24-hour bronchodilator efficacy of single doses of indacaterol in subjects with COPD: comparison with placebo and formoterol. Curr Med Res Opin 2009, 25:463-470. 10.1185/03007990802675096, 19192991.
14. Rennard S, Bantje T, Centanni S, Chanez P, Chuchalin A, D'Urzo A, Kornmann O, Perry S, Jack D, Owen R, Higgins M. A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison. Respir Med 2008, 102:1033-1044. 10.1016/j.rmed.2008.02.001, 18479895.
15. 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. Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J 2008, 31:416-469. 10.1183/09031936.00099306, 18238951.
16. Sturtz S, Ligges U, Gelman A. R2WinBUGS: A Package for Running WinBUGS from R. Journal of Statistical Software 2005, 12:1-16.
17. Bonate P. Linear mixed effects models. Pharmacokinetic-pharmacodynamic modeling and simulation 2006, 181-204. New York, USA: Springer, Bonate P.
18. GOLD Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. 2007, GOLD.
19. GOLD Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. 2009, GOLD.
20. Cazzola M, Matera MG, Lotvall J. Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease. Expert Opin Investig Drugs 2005, 14:775-783. 10.1517/13543784.14.7.775, 16022567.
21. Jones P, Lareau S, Mahler DA. Measuring the effects of COPD on the patient. Respir Med 2005, 99:S11-S18.
22. Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest 1984, 85:751-758. 10.1378/chest.85.6.751, 6723384.
23. Jones PW, Donohue J, Nedelman J, Pinault G, Pascoe S. Correlating changes in lung function with patient reported outcomes in COPD (abstract). Thorax 2010, 65:A141.