The lung function profile of once-daily tiotropium and olodaterol via respimat® is superior to that of twice-daily salmeterol and fluticasone propionate via a accuhaler® (Energito® study)

International Journal of COPD

Volumn 11, Issue , 2016, Pages 193-205

  Beeh, Kai Michael ^a   Derom, Eric ^b   Echave Sustaeta, José ^c   Grönke, Lars ^d   Hamilton, Alan ^e   Zhai, Dongmei ^f   Bjermer, Leif ^g  

^a Institut fur Atemwegsforschung INSAF   (Germany)

^b GHENT UNIVERSITY HOSPITAL   (Belgium)

^c Hospital Universitario Quiron   (Spain)

^d BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^e BOEHRINGER INGELHEIM CANADA LTD   (Canada)

^f SYNEOS HEALTH   (United States)

^g LUND UNIVERSITY   (Sweden)

Author keywords

COPD; FEV1; Inhaled corticosteroid; Lung function; Maintenance treatment; Tiotropium

Indexed keywords

BETA ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; FLUTICASONE PROPIONATE; FLUTICASONE PROPIONATE PLUS SALMETEROL; LONG ACTING DRUG; MUCOLYTIC AGENT; OLODATEROL; OXYGEN; PLACEBO; SALMETEROL; SHORT ACTING DRUG; TIOTROPIUM BROMIDE; XANTHINE; BENZOXAZINE DERIVATIVE; BRONCHODILATING AGENT; DRUG COMBINATION; FLUTICASONE; SALMETEROL XINAFOATE;

ADULT; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BACKACHE; BRONCHODILATATION; CHRONIC OBSTRUCTIVE LUNG DISEASE; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; DIARRHEA; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG SAFETY; DRY POWDER INHALER; DYSPHONIA; DYSPNEA; FEMALE; FORCED EXPIRATORY VOLUME; HEADACHE; HIGH RISK PATIENT; HUMAN; LABORATORY TEST; LUNG FUNCTION; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OROPHARYNX PAIN; PHASE 3 CLINICAL TRIAL; PHYSICAL EXAMINATION; PNEUMONIA; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SOFT MIST INHALER; AGED; DRUG ADMINISTRATION; DRUG COMBINATION; DRUG MONITORING; INHALATIONAL DRUG ADMINISTRATION; LUNG FUNCTION TEST; MIDDLE AGED; NEBULIZER; PATHOPHYSIOLOGY; PROCEDURES; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; AGED; BENZOXAZINES; BRONCHODILATOR AGENTS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; DRUG MONITORING; FEMALE; FLUTICASONE; HUMANS; MALE; MIDDLE AGED; NEBULIZERS AND VAPORIZERS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RESPIRATORY FUNCTION TESTS; SALMETEROL XINAFOATE; TIOTROPIUM BROMIDE; TREATMENT OUTCOME;

EID: 84957094801     PISSN: 11769106     EISSN: 11782005     Source Type: Journal    
DOI: 10.2147/COPD.S95055     Document Type: Article

References (28)

1. Vogelmeier CF, Bateman ED, Pallante J, et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMI­NATE): a randomised, double-blind, parallel group study. Lancet Respir Med. 2013;1(1):51–60.
2. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstruc­tive Pulmonary Disease; [updated February 18, 2015]. Available from: http://www.goldcopd.org/uploads/users/files/GOLD_Report_2015_Feb18.pdf. Accessed September 30, 2015.
3. Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008;359(15): 1543–1554.
4. Bateman ED, Tashkin D, Siafakas N, et al. A one-year trial of tiotropium Respimat® plus usual therapy in COPD patients. Respir Med. 2010;104(10):1460–1472.
5. Yohannes AM, Willgoss TG, Vestbo J. Tiotropium for treatment of stable COPD: a meta-analysis of clinically relevant outcomes. Respir Care. 2011;56(4):477–487.
6. Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salme­terol for the prevention of exacerbations of COPD. N Engl J Med. 2011;364(12):1093–1103.
7. O’Donnell DE, Flüge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J. 2004;23(6):832–840.
8. Wise RA, Anzueto A, Cotton D, et al. Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med. 2013;369(16): 1491–1501.
9. Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2–4). Eur Respir J. 2015;45(4):969–979.
10. Beeh K-M, Westerman J, Kirsten A-M, et al. The 24-h lung-function profile of once-daily tiotropium and olodaterol fixed-dose combina­tion in chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2015;32:53–59.
11. Global Initiative for Asthma. Diagnosis of Diseases of Chronic Airflow Limitation: Asthma COPD and Asthma – COPD Overlap Syndrome (ACOS); [updated 2014]. Available from: http://www.goldcopd.org/uploads/users/files/AsthmaCOPDOverlap.pdf. Accessed July 30, 2015.
12. Roche N, Pribil C, Van Ganse E, et al. Real-life use of fluticasone propionate/salmeterol in patients with chronic obstructive pulmonary disease: a French observational study. BMC Pulm Med. 2014;14:56.
13. Drivenes E, Østrem A, Melbye H. Predictors of ICS/LABA prescrib­ing in COPD patients: a study from general practice. BMC Fam Pract. 2014;15:42.
14. Price D, West D, Brusselle G, et al. Management of COPD in the UK primary-care setting: an analysis of real-life prescribing patterns. Int J Chron Obstruct Pulmon Dis. 2014;9:889–905.
15. Watz H, Ferguson GT, Grönke L, Vob F, Abrahams R, Buhl R. Inhaled corticosteroid plus long-acting β2-agonist therapy is overused in the treatment of patients with chronic obstructive pulmonary disease: post hoc analyses of two 1-year studies [abstract]. Am J Respir Crit Care Med. 2015;191:A5784.
16. Tricco AC, Strifler L, Veroniki AA, et al. Comparative safety and effec­tiveness of long-acting inhaled agents for treating chronic obstructive pulmonary disease: a systematic review and network meta-analysis. BMJ Open. 2015;5(10):e009183.
17. Bouyssou T, Casarosa P, Naline E, et al. Pharmacological character­ization of olodaterol, a novel inhaled β2-adrenoceptor agonist exerting a 24-hour-long duration of action in preclinical models. J Pharmacol Exp Ther. 2010;334(1):53–62.
18. Lange P, Aumann J-L, Derom E, et al. The 24-h FEV1 time profile of olodaterol QD delivered via Respimat® in COPD: results from two 6-week studies [abstract 4635]. Eur Respir J. 2013;42(7): 982s.
19. Ferguson G, Feldman G, Hofbauer P, et al. Lung function efficacy of olodaterol QD delivered via Respimat® in COPD patients: results from two 48-week studies [abstract 187]. Eur Respir J. 2013;42(57):5s.
20. Beeh K-M, Derom E, Echave-Sustaeta J, et al. ENERGITO: efficacy and safety of once-daily combined tiotropium + olodaterol versus twice-daily combined fluticasone propionate + salmeterol. Abstract presented at: The European Respiratory Society International Confer­ence; September 26–30, 2015; Amsterdam.
21. Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Eur Respir J. 1993;6(16):5–40.
22. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstruc­tive Pulmonary Disease; 2010 [updated 2010]. Available from: http://www.goldcopd.org/uploads/users/files/GOLDReport_April112011.pdf. Accessed August 12, 2015.
23. Miller MR, Hankinson J, Brusasco V, et al. Standardisation of spirom­etry. Eur Respir J. 2005;26(2):319–338.
24. Kenward MG, Roger JH. The use of baseline covariates in crossover studies. Biostatistics. 2010;11(1):1–17.
25. Pisi R, Aiello M, Zanini A, et al. Small airway dysfunction and flow and volume bronchodilator responsiveness in patients with chronic obstruc­tive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2015;10:1191–1197.
26. Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011;12:161.
27. Singh D, Ferguson GT, Bolitschek J, et al. Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015;109(10):1312–1319.
28. Magnussen H, Disse B, Rodriguez-Roisin R, et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014;371(14):1285–1294.