The effect of fluticasone furoate/umeclidinium in adult patients with asthma: A randomized, dose-ranging study

Respiratory Medicine

Volumn 109, Issue 1, 2016, Pages 54-62

  Lee, Laurie A ^a   Yang, Shuying ^b   Kerwin, Edward ^c   Trivedi, Roopa ^a   Edwards, Lisa D ^a   Pascoe, Steven ^a  

^a GLAXOSMITHKLINE   (United States)

^b GLAXOSMITHKLINE   (United Kingdom)

^c Clinical Research Institute of Southern Oregon PC   (United States)

Author keywords

Asthma; Fixed dose combination; Inhaled corticosteroid; Muscarinic antagonist; Trough FEV1

Indexed keywords

FLUTICASONE FUROATE; UMECLIDINIUM; VILANTEROL; ANDROSTANE DERIVATIVE; BRONCHODILATING AGENT; DRUG COMBINATION; GLUCOCORTICOID; MUSCARINIC RECEPTOR BLOCKING AGENT;

ADULT; ALLERGIC RHINITIS; ARTHRALGIA; ARTICLE; ASTHMA; BRONCHITIS; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPHONIA; FEMALE; FORCED EXPIRATORY VOLUME; HEADACHE; HERPETIC STOMATITIS; HUMAN; HYPERTENSION; INFLUENZA; MAJOR CLINICAL STUDY; MALE; NAUSEA; PEAK EXPIRATORY FLOW; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; RHINITIS; RHINOPHARYNGITIS; SUPRAVENTRICULAR PREMATURE BEAT; TASTE DISORDER; THROAT IRRITATION; THRUSH; TOOTH PAIN; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VIRAL PHARYNGITIS; ADOLESCENT; CLINICAL TRIAL; DRUG COMBINATION; DRUG EFFECTS; INHALATIONAL DRUG ADMINISTRATION; MIDDLE AGED; MULTICENTER STUDY; PATHOPHYSIOLOGY; TREATMENT OUTCOME; YOUNG ADULT;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; ANDROSTADIENES; ASTHMA; BRONCHODILATOR AGENTS; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; FORCED EXPIRATORY VOLUME; GLUCOCORTICOIDS; HUMANS; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84919711899     PISSN: 09546111     EISSN: 15323064     Source Type: Journal    
DOI: 10.1016/j.rmed.2014.09.012     Document Type: Article

References (26)

1. E.D. Bateman, H.A. Boushey, and J. Bousquet Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study Am J Respir Crit Care Med 170 2004 836 844
2. M.R. Hetzel, and T.J. Clark Comparison of normal and asthmatic circadian rhythms in peak expiratory flow rate Thorax 35 1980 732 738
3. H.H. Kariyawasam, M. Aizen, and J. Barkans Remodeling and airway hyperresponsiveness but not cellular inflammation persist after allergen challenge in asthma Am J Respir Crit Care Med 175 2007 896 904
4. J. Schwarze, E. Hamelmann, and K.L. Bradley Respiratory syncytial virus infection results in airway hyperresponsiveness and enhanced airway sensitization to allergen J Clin Invest 100 1997 226 233
5. GOLD. Global strategy for the diagnosis, management and prevention of Chronic Obstructive Pulmonary Disease http://www.goldcopd.org/ [accessed May 2014].
6. H.A. Kerstjens, M. EngeL, and R. Dahl Tiotropium in asthma poorly controlled with standard combination therapy N Engl J Med 367 2012 1198 1207
7. S.P. Peters, S.J. Kunselman, and N. Icitovic Tiotropium bromide step-up therapy for adults with uncontrolled asthma N Engl J Med 363 2010 1715 1726
8. Global initiative for asthma (GINA). Global strategy for asthma management and prevention http://www.ginasthma.org/ [accessed August 2014].
9. M. Salmon, M.A. Luttmann, and J.J. Foley Pharmacological characterization of GSK573719 (umeclidinium): a novel, long-acting, inhaled antagonist of the muscarinic cholinergic receptors for treatment of pulmonary diseases J Pharmacol Exp Ther 345 2013 260 270
10. A. Allen, P. Bareille, and V. Rousell Fluticasone furoate, a novel inhaled corticosteroid, demonstrates prolonged lung absorption kinetics in man compared with inhaled fluticasone propionate Clin Pharmacokinet 52 2013 37 42
11. E.R. Bleecker, E.D. Bateman, and W.W. Busse Once-daily fluticasone furoate is efficacious in patients with symptomatic asthma on low-dose inhaled corticosteroids Ann Allergy. Asthma. Immunol 109 2012 353 358 e4
12. H. Medley, S. Orozco, and A. Allen Efficacy and safety profile of fluticasone furoate administered once daily in the morning or evening: a randomized, double-blind, double-dummy, placebo-controlled trial in adult and adolescent patients with persistent bronchial asthma Clin Ther 34 2012 1683 1695
13. G.T. O'Connor, D. Sparrow, and S.T. Weiss A prospective longitudinal study of methacholine airway responsiveness as a predictor of pulmonary-function decline: the Normative Aging Study Am J Respir Crit Care Med 152 1995 87 92
14. World Medical Association. WMA Declaration of Helsinki - ethical principles for medical research involving human subjects http://www.wma.net/en/30publications/10policies/b3/index.html [accessed May 2014].
15. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH harmonised tripartite guideline: guideline for good clinical practice E6(1) http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E6-R1/Step4/E6-R1-Guideline.pdf [accessed May 2014].
16. National Institutes of Health Guidelines for the diagnosis and management of asthma: expert panel report 3 National asthma Education and Prevention Program, Full Report 2007 US Department of Health and Human Services
17. J.L. Hankinson, S.M. Kawut, and E. Shahar Performance of american thoracic society-recommended spirometry reference values in a multiethnic sample of adults: the multi-ethnic study of atherosclerosis (mesa) lung study Chest 137 2010 138 145
18. J. Hankinson, J. Odencrantz, and K. Fedan Spirometric reference values from a sample of the general U.S. population Am J Respir Crit Care Med 159 1999 179 187
19. R.A. Nathan, C.A. Sorkness, and M. Kosinski Development of the asthma control test: a survey for assessing asthma control J Allergy Clin Immunol 113 2004 59 65
20. E. Sato, S. Koyama, and Y. Okubo Acetylcholine stimulates alveolar macrophages to release inflammatory cell chemotactic activity Am J Physiol 274 1998 L970 L979
21. J. Tamaoki, A. Chiyotani, and E. Tagaya Effect of long term treatment with oxitropium bromide on airway secretion in chronic bronchitis and diffuse panbronchiolitis Thorax 49 1994 545 548
22. A. Church, M. Beerahee, and J. Brooks Dose response of umeclidinium administered once or twice daily in patients with COPD: a randomised cross-over study BMC. Pulm Med 14 2014 2
23. J.F. Donohue, A. Anzueto, and J. Brooks A randomized, double-blind dose-ranging study of the novel LAMA GSK573719 in patients with COPD Respir Med 106 2012 970 979
24. L. Lee, A. Briggs, and L.E. Edwards A randomised, three-period crossover study of umeclidinium as monotherapy in adult patients with asthma Respir Med 109 2015 63 73
25. S.P. Peters, E.R. Bleecker, and S.J. Kunselman Predictors of response to tiotropium versus salmeterol in asthmatic adults J Allergy. Clin Immunol 132 2013 1068 1074
26. A. ten Brinke, A.H. Zwinderman, and P.J. Sterk Factors associated with persistent airflow limitation in severe asthma Am J Respir Crit Care. Med 164 2001 744 748