Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids

Journal of Negative Results in BioMedicine

Volumn 13, Issue 1, 2014, Pages

  Lötvall, Jan ^a   Bateman, Eric D ^b   Busse, William W ^c   O'Byrne, Paul M ^d   Woodcock, Ashley ^e   Toler, William T ^f   Jacques, Loretta ^g   Goldfrad, Caroline ^g   Bleecker, Eugene R ^h  

^a UNIVERSITY OF GOTHENBURG   (Sweden)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

^c UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^d MCMASTER UNIVERSITY   (Canada)

^e UNIVERSITY OF MANCHESTER   (United Kingdom)

^f GLAXOSMITHKLINE   (United States)

^g GLAXOSMITHKLINE   (United Kingdom)

^h WAKE FOREST SCHOOL OF MEDICINE   (United States)

Author keywords

Asthma; Bronchodilators; Long acting beta agonist; Lung function; Placebo response; Randomised trial; Salmeterol; Vilanterol

Indexed keywords

FLUTICASONE PROPIONATE; PLACEBO; SALMETEROL; VILANTEROL; BENZYL ALCOHOL DERIVATIVE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; CHLOROBENZENE; CORTICOSTEROID; SALBUTAMOL;

ADULT; ARTICLE; ASTHMA; BRONCHODILATING ACTIVITY; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DISEASE CONTROL; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRY POWDER INHALER; ELECTROCARDIOGRAM; FEMALE; FOLLOW UP; FORCED EXPIRATORY VOLUME; HUMAN; LUNG FUNCTION; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; MULTICENTER STUDY; OROPHARYNX PAIN; OUTCOME ASSESSMENT; PARALLEL DESIGN; PATIENT COMPLIANCE; PEAK EXPIRATORY FLOW; PHASE 3 CLINICAL TRIAL; PLACEBO EFFECT; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SUDDEN DEATH; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; VITAL SIGN; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; COMPARATIVE STUDY; INHALATIONAL DRUG ADMINISTRATION; MIDDLE AGED; YOUNG ADULT;

ADMINISTRATION, INHALATION; ADRENAL CORTEX HORMONES; ADRENERGIC BETA-2 RECEPTOR AGONISTS; ADULT; ALBUTEROL; ASTHMA; BENZYL ALCOHOLS; CHLOROBENZENES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; YOUNG ADULT;

EID: 84902472175     PISSN: None     EISSN: 14775751     Source Type: Journal    
DOI: 10.1186/1477-5751-13-9     Document Type: Article

References (19)

1. ABC of allergies: asthma and allergy. Neuman Taylor AJ, BMJ 1998 316 997 999 10.1136/bmj.316.7136.997 9550963
2. Global initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention http://www.ginasthma.org/local/uploads/files/GINA- Report-2014.pdf
3. Etiology of asthma exacerbations. Sykes A, Johnston SL, J Allergy Clin Immunol 2008 122 685 688 10.1016/j.jaci.2008.08.017 19014758
4. An official American thoracic society/European respiratory society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE, American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations, Am J Respir Crit Care Med 2009 180 59 99 10.1164/rccm.200801-060ST 19535666
5. 1 is associated with risk of asthma attacks in long-term follow-up. Kitch BT, Paltiel AD, Kuntz KM, Dockery DW, Schouten JP, Weiss ST, Fuhlbrigge AL, Chest 2004 126 1875 1882 10.1378/chest.126.6.1875 15596687
6. Synthesis and structure-activity relationships of long-acting beta2 adrenergic receptor agonists incorporating metabolic inactivation: an antedrug approach. Procopiou PA, Barrett VJ, Bevan NJ, Biggadike K, Box PC, Butchers PR, Coe DM, Conroy R, Emmons A, Ford AJ, Holmes DS, Horsley H, Kerr F, Li-Kwai-Cheung AM, Looker BE, Mann IS, McLay IM, Morrison VS, Mutch PJ, Smith CE, Tomlin P, J Med Chem 2010 53 4522 4530 10.1021/jm100326d 20462258
7. In vitro pharmacological characterization of vilanterol, a novel long acting β2-adrenoceptor agonist with 24-hour duration of action. Slack RJ, Barrett VJ, Morrison VS, Sturton RG, Emmons AJ, Ford AJ, Knowles RG, J Pharmacol Exp Ther 2013 344 218 230 10.1124/jpet.112.198481 23131596
8. 24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids. Lötvall J, Bateman ED, Bleecker ER, Busse WW, Woodcock A, Follows R, Lim J, Stone S, Jacques L, Haumann B, Eur Respir J 2012 40 570 579 10.1183/09031936.00121411 22362859
9. Efficacy and optimal dosing interval of the long-acting beta2 agonist, vilanterol, in persistent asthma: a randomised trial. Sterling R, Lim J, Frith L, Snowise NG, Jacques L, Haumann B, Respir Med 2012 106 1110 1115 10.1016/j.rmed.2012.03.007 22520084
10. Dose effect of once-daily fluticasone furoate in persistent asthma: a randomized trial. Bateman ED, Bleecker ER, Lötvall J, Woodcock A, Forth R, Medley H, Davis AM, Jacques L, Haumann B, Busse WW, Respir Med 2012 106 642 650 10.1016/j.rmed.2012.01.004 22342538
11. Once-daily fluticasone furoate is efficacious in patients with symptomatic asthma on low-dose inhaled corticosteroids. Bleecker ER, Bateman ED, Busse WW, Woodcock A, Frith L, House KW, Jacques L, Davis AM, Haumann B, Lötvall J, Ann Allergy Asthma Immunol 2012 109 353 389 e4 10.1016/j.anai.2012.08.017 23062392
12. Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial. Busse WW, Bleecker ER, Bateman ED, Lötvall J, Forth R, Davis AM, Jacques L, Haumann B, Woodcock A, Thorax 2012 67 35 41 10.1136/thoraxjnl-2011-200308 21828231
13. Efficacy and safety of fluticasone furoate 100 μg once-daily in patients with persistent asthma: a 24-week placebo and active-controlled randomised trial. Lötvall J, Bleecker ER, Busse WW, O'Byrne PM, Woodcock A, Kerwin EM, Stone S, Forth R, Jacques L, Bateman ED, Respir Med 2014 108 1 41 49 10.1016/j.rmed.2013.11.009 24295556
14. Beclomethasone/formoterol vs fluticasone/salmeterol inhaled combination in moderate to severe asthma. Papi A, Paggiaro P, Nicolini G, Vignola AM, Fabbri LM, ICAT SE, Study Group, Allergy 2007 62 1182 1188 10.1111/j.1398-9995.2007. 01493.x 17845589
15. Improved adherence with once-daily versus twice-daily dosing of mometasone furoate administered via a dry powder inhaler: a randomized open-label study. Price D, Robertson A, Bullen K, Rand C, Horne R, Staudinger H, BMC Pulm Med 2010 10 1 10.1186/1471-2466-10-1 20051135
16. Achieving asthma control in practice: understanding the reasons for poor control. Haughney J, Price D, Kaplan A, Chrystyn H, Horne R, May N, Moffat M, Versnel J, Shanahan ER, Hillyer EV, Tunsäter A, Bjermer L, Respir Med 2008 102 1681 1693 10.1016/j.rmed.2008.08.003 18815019
17. The relationship between clinical outcomes and medication adherence in difficult-to-control asthma. Murphy AC, Proeschal A, Brightling CE, Wardlaw AJ, Pavord I, Bradding P, Green RH, Thorax 2012 67 751 753 10.1136/thoraxjnl-2011- 201096 22436168
18. Publication bias in clinical research. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR, Lancet 1991 337 867 872 10.1016/0140-6736(91)90201-Y 1672966
19. Compliance, adherence, and concordance: implications for asthma treatment. Horne R, Chest 2006 130 Suppl 1 65S 72S 16840369