Buhl, R

Derom, Eric

Ferguson, G

Groenke, L

Hamilton, A

Huisman, H

Korducki, L

Maltais, F

Pizzichini, E

Reid, J

Tetzlaff, K

Waitere-Wijker, S

Watz, H

Thorax

English

Ghent University Academic Bibliography

care and office based chest medicine clinics. A convenience sam-ple of 500 was selected.Results We report the characteristics of the first 250 COPDpatients from our ongoing 500 patient survey.Basic demographics 55% Male, 45% Female. Mean age patients68 ± 12 yrs, all patients were previous smokers with 56 ± 10pkt/yrs smoking history. 34% remain current smokers.Mean FEV1 48% ± 10%, Mean FEV1/FVC ratio 49% ± 10.Median mMRC dyspnea score 2. Mean CAT score 18 ± 10(Range 0–38).GOLD Stage Classification 13% GOLD Stage A, 67% GOLDStage B, 1% GOLD Stage C and 19% GOLD Stage D.Current treatment LAMA (long-acting muscarinic antagonist)was prescribed to over 90% of all patients in groups B, C and Dwhereas monotherapy with LABA (long acting beta-agonist) ordual bronchodilation with LABA/LAMA therapy was prescribedto less than 5%.There was significant overtreatment with ICS/LABA in all cate-gories with high dose ICS (inhaled corticosteroid) being preferred.20% of patients in GOLD Stage A where receiving Tripletherapy (LAMA + ICS/LABA) and a further 20% where receiv-ing monotherapy with ICS/LABA, yet had no history ofexacerbations.30% of patients in GOLD Stage B where receiving Triple ther-apy (LAMA + ICS/LABA) yet had no history of exacerbations.Conclusion Current Canadian Guidelines and the GOLD strat-egy focus on symptom relief and striving to prevent exacerba-tions with step-wise prescription of short and long-actingbronchodilators with individual or combinations of LAMA,LABA, LAMA/LABA or ICS/LABA inhalers. Patients in GOLDGroup C are rare. Current prescription choices in our surveydoes not reflect current evidence or guidelines. We report aheavy reliance on ICS/LABA along with over prescription of tri-ple therapy at all stages of disease.P253 META – ANALYSIS ON STATINS IN CHRONICOBSTRUCTIVE PULMONARY DISEASEGplc Ambrocio, IA Roque, II MPPC Jorge. Section of Pulmonary Medicine, Department ofMedicine, University of the Philippines – Philippine General Hospital, Manila, Philippines10.1136/thoraxjnl-2014-206260.381Background Chronic obstructive pulmonary disease (COPD) isan inflammatory lung disease characterised by progressive air-flow limitation. Statins have anti-inflammatory and immunomo-dulating properties that could alter inflammation of the airways.The objective of this study is to systematically evaluate the effec-tiveness of adjunct statin therapy in improving exercise toleranceand pulmonary function indices in patients with chronic obstruc-tive pulmonary disease.Search strategy and inclusion criteria A thorough search wasdone using Medline and PubMed, with limits set on studiesinvolving humans in a randomised control trial in English thatexamined the effect of statins in COPD.Study manoeuvres All the articles retrieved were appraised sepa-rately and independently by two reviewers for its applicability,validity and the methodological quality of the randomised con-trol trials by assessing allocation, blinding, and if follow up ratewas adequate. Disagreements between the reviewers wereresolved by consensus.Statistical analysis Data collected were analysed using ReviewManager Version 5.2.Results A total of two articles met the end criteria. Outcomeshows improvement in exercise time (treadmill test) at 95% CI,with statistically significant benefit with mean difference of335.18 [253.93, 416.43] favouring Pravastatin group. The stud-ies show inconclusive results for Pravastatin in improving FEV1(%) with 95% CI with mean difference of 0.05 [-4.61, 4.7]. Theoutcome in total lung capacity shows inconclusive results butshows a trend toward benefit with 95% CI with mean differenceof -0.08 [-0.46, 0.30]. Inspiratory capacity results at 95% CIwith mean difference of 0.13 [-0.06, 0.32] showed an inconclu-sive outcome but has a trend toward benefit. Improvement inthe Borg dyspnea score at 95% CI, showing statistically signifi-cant benefit with mean difference of -2.91 [-3.19, -2.63] favour-ing the Pravastatin group.Conclusions Statins already have an established role in treatingcardiovascular patients because of their cholesterol-lowering abil-ity, but also have anti-inflammatory and immunomodulatoryeffects that are beneficial in airway inflammation in COPD. Sta-tin administration to COPD patients showed amelioration inexercise tolerance, improvement in dyspnea scores and augmen-tation in pulmonary function indices. Thus, statins may be usefulas adjunct to currently available therapies as well as improve-ment in lipid status.P254 ONCE-DAILY TIOTROPIUM AND OLODATEROL FIXED-DOSE COMBINATION VIA THE RESPIMAT® IMPROVESOUTCOMES VERSUS MONO-COMPONENTS IN COPD INTWO 1-YEAR STUDIES1R Buhl, 2E Derom, 3G Ferguson, 4E Pizzichini, 5J Reid, 6H Watz, 7L Grönke, 8A Hamilton,7K Tetzlaff, 9L Korducki, 10H Huisman, 10S Waitere-Wijker, 11F Maltais. 1PulmonaryDepartment, Mainz University Hospital,, Mainz, Germany; 2Ghent University Hospital,Ghent, Belgium; 3Pulmonary Research Institute of Southeast Michigan, Livonia,Michigan, USA; 4NUPAIVA (Asthma Research Centre), Universidade Federal de SantaCatarina, Santa Catarina, Brazil; 5Dunedin School of Medicine, University of Otago,Dunedin, New Zealand; 6Pulmonary Research Institute at Lung Clinic Grosshansdorf,Airway Research Center North, Member of the German Center for Lung Research,Grosshansdorf, Germany; 7Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim,Germany; 8Boehringer Ingelheim, Burlington, Ontario, Canada; 9Boehringer IngelheimPharmaceuticals Inc., Ridgefield, Connecticut, USA; 10Boehringer Ingelheim B. V.,Alkmaar, The Netherlands; 11Centre de Recherche, Institut Universitaire de Cardiologie Etde Pneumologie de Québec, Québec, Canada10.1136/thoraxjnl-2014-206260.382Introduction Tiotropium (T), a once-daily long-acting muscar-inic antagonist, is a well-established first-line maintenance treat-ment in chronic obstructive pulmonary disease (COPD);olodaterol (O) is a once-daily long-acting b2-agonist that hasrecently gained approval in several countries. Two Phase III rep-licate pivotal studies assessed the efficacy and safety of fixed-dose combinations of T and O (T+O) delivered via Respimat®Soft Mist™ inhaler in patients with GOLD 2–4 COPD.Methods Two 52-week, double-blind, parallel-group studies rand-omised 5162 patients to O 5 mg, T 2.5 mg, T 5 mg, T+O 2.5/5 mgor T+O 5/5 mg. Primary efficacy end points were trough forcedexpiratory volume in 1 second (FEV1) response (ie change frombaseline), FEV1 area under the curve from 0–3 h and St George’sRespiratory Questionnaire (SGRQ) total score after 24 weeks.Pooled data from the two studies are presented here; lung functionfrom the individual studies will subsequently be provided.Results All treatments resulted in clinically relevant improve-ments in lung function, with significant increases with both T+O doses over the individual components (p1 responses were0.055 L (O 5 mg), 0.073 L (T 2.5 mg), 0.080 L (T 5 mg), 0.118Poster sessionsA188 Thorax 2014;69(Suppl 2):A1–A233group.bmj.com on August 21, 2015 - Published by http://thorax.bmj.com/Downloaded from L (T+O 2.5/5 mg) and 0.140 L (T+O 5/5 mg). SGRQ totalscores improved by 5.1 (O 5 mg), 5.7 (T 2.5 mg), 5.6 (T 5 mg),6.2 (T+O 2.5/5 mg) and 6.8 points (T+O 5/5 mg); differencesbetween T+O 5/5 mg and O 5 mg and T 5 mg were statisticallysignificant (pConclusions T+O 5/5 mg significantly improved lung functionand provided symptomatic benefit over O 5 mg and T 5 mg.P255 ONCE-DAILY TIOTROPIUM RESPIMAT® ADD-ON TO ATLEAST ICS MAINTENANCE THERAPY REDUCESEXACERBATION RISK IN PATIENTS WITHUNCONTROLLED SYMPTOMATIC ASTHMA1DMG Halpin, 2P Paggiaro, 3E Bleecker, 4M Engel, 4P Moroni-Zentgraf, 4H Schmidt, 5HAMKerstjens. 1Royal Devon and Exeter Hospital, Exeter, UK; 2University of Pisa, Pisa, Italy;3Center for Genomics and Personalized Medicine, Wake Forest School of Medicine,Winston-Salem, USA; 4Boehringer Ingelheim Pharma GmbH and Co. KG, Biberach anDer Riss, Germany; 5University Medical Center Groningen, University of Groningen,Groningen, The Netherlands10.1136/thoraxjnl-2014-206260.383Background A reduction in asthma exacerbation risk may pro-vide improvements in clinical burden, patient experience andhealthcare costs. In Phase III trials, once-daily tiotropium (deliv-ered via the Respimat® SoftMist™ inhaler) added on to at leastinhaled corticosteroids (ICS) improved lung function in patientswith symptomatic asthma. We investigated exacerbation risk ineach trial.Methods Five Phase III, double-blind, placebo-controlled, paral-lel-group trials in patients with symptomatic asthma. Patientsreceived tiotropium Respimat® 5 mg or placebo as add-on to atleast ICS maintenance therapy (Table). Pre-planned co-primaryor secondary end points were time to first severe exacerbationand time to any asthma worsening.Results Mean baseline% of predicted forced expiratory volume in1 second, seven-question Asthma Control Questionnaire score andICS dose (mg) were: 56.0 ± 13.1, 2.6 ± 0.7, 1198 ± 539 (Primo-TinA-asthma®); 75.1 ± 11.5, 2.2 ± 0.5, 660 ± 213 (MezzoTinA-asthma®); 77.7 ± 11.9, 2.1 ± 0.4, 381 ± 78 (GraziaTinA-asthma®). Tiotropium Respimat® 5 mg reduced severe asthmaexacerbation risk by at least 21% in all three severity cohorts(Table) and asthma worsening risk versus placebo in all trials, witha statistically significant reduction in the PrimoTinA-asthma® trial.Conclusion Once-daily tiotropium Respimat® 5 mg add-on to atleast ICS maintenance therapy consistently reduced exacerba-tions across asthma severities and so may be a beneficial add-onoption to reduce current and future exacerbation risk.P256 SAFETY OF ONCE-DAILY TIOTROPIUM ANDOLODATEROL FIXED-DOSE COMBINATION VIA THERESPIMAT IN CHRONIC OBSTRUCTIVE PULMONARYDISEASE IN TWO 1-YEAR STUDIES1R Buhl, 2R Abrahams, 3L Bjermer, 4E Derom, 5M Fležar, 6J Hébert, 7A Veale, 8L Grönke, 9AHamilton, 8K Tetzlaff, 10L Korducki, 11H Huisman, 11S Waitere-Wijker, 12L McGarvey.1Pulmonary Department, Mainz University Hospital, Mainz, Germany; 2MorgantownPulmonary Associates, Morgantown, West Virginia, USA; 3Department of RespiratoryMedicine and Allergology, Lund University, Lund, Sweden; 4Ghent University Hospital,Ghent, Belgium; 5Klinika Golnik, Golnik, Slovenia; 6Centre de Recherche Appliquée enAllergie de Québec (CRAAQ), Québec, Canada; 7Department of Respiratory Medicine,The Queen Elizabeth Hospital, Adelaide, Australia; 8Boehringer Ingelheim Pharma GmbHand Co. KG, Ingelheim, Germany; 9Boehringer Ingelheim, Burlington, Ontario, Canada;10Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA; 11BoehringerIngelheim B. V., Alkmaar, The Netherlands; 12Centre for Infection and Immunity, Schoolof Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast, Belfast, UK10.1136/thoraxjnl-2014-206260.384Introduction The fixed-dose combination (FDC) of tiotropium(T), a once-daily long-acting muscarinic antagonist, and oloda-terol (O), a once-daily long-acting b2-agonist, is currently beingevaluated in chronic obstructive pulmonary disease (COPD).Two 52-week, Phase III replicate pivotal studies were con-ducted to assess the efficacy and safety of FDCs of T and O (T+O) delivered via Respimat® Soft Mist™ inhaler in patients(pts) with GOLD Stage 2–4 COPD. Pooled safety data from thetwo studies are presented here.Methods These were double-blind, randomised, parallel-groupstudies with 5 arms: O 5 mg, T 2.5 mg, T 5 mg, T+O 2.5/5 mg,T+O 5/5 mg. Key inclusion criteria were: age ≥40 years, diagno-sis of COPD, smoking history >10 pack-years. Pts with a historyof asthma or significant disease other than COPD wereexcluded. Adverse events (AEs) were reported throughout thestudies.Results A total of 5162 pts were randomised and treated. Ingeneral, AEs, serious AEs and fatal AEs were balanced acrosstreatment groups. In particular, frequencies of AEs in the cardiacdisorders System Organ Class (SOC) and respiratory disordersSOC were similar.Abstract P255 Table 1Severe asthma exacerbations,proportion of patients (%)TrialBackgroundmedicationTiotropiumRespimat® 5 mg PlaceboHRa(95% CI) p valuePrimoTinA-asthma®bICS + LABA(>800 µg budesonideor equivalent)122/453(26.9) 149/454 (32.8)0.79(0.62, 1.00) 0.034MezzoTinA-asthma®cICS (400–800 mgbudesonide orequivalent)31/513(6.0)43/518(8.3)0.72(0.45, 1.14) 0.164GraziaTinA-asthma®dICS (200–400 mgbudesonide orequivalent)1/151(0.7)4/151(2.6)0.25(0.03, 2.24) 0.216aHazard ratio; time to first severe exacerbation (versus placebo, <1 favours tiotropiumRespimat®); bBaseline to Week 48; cBaseline to Week 24; dBaseline to time of last eventAbstract P256 Table 1Pts with AE,%O 5 mgn = 1038T 2.5 mgn = 1032T 5 mgn = 1033T+O2.5/5 mgn = 1030T+O5/5 mgn = 1029Total AEs 76.6 73.4 73.3 74.7 74.0Serious AEs 17.4 15.1 16.7 16.3 16.4Fatal AEs 1.3 1.2 1.6 1.4 1.7Cardiac disorders* 5.7 5.8 5.3 5.8 4.5Respiratory,thoracic andmediastinal disorders* 45.3 43.9 42.7 38.2 39.4*MedDRA SOCPoster sessionsThorax 2014;69(Suppl 2):A1–A233 A189group.bmj.com on August 21, 2015 - Published by http://thorax.bmj.com/Downloaded from StudiesVersus Mono-components In Copd In Two 1-yearCombination Via The Respimat® Improves Outcomes Once-daily Tiotropium And Olodaterol Fixed-dose P254Tetzlaff, L Korducki, H Huisman, S Waitere-Wijker and F MaltaisR Buhl, E Derom, G Ferguson, E Pizzichini, J Reid, H Watz, L Grönke, A Hamilton, Kdoi: 10.1136/thoraxjnl-2014-206260.3822014 69: A188-A189 Thorax  http://thorax.bmj.com/content/69/Suppl_2/A188.2Updated information and services can be found at: These include:serviceEmail alertingright corner of the online article. Receive free email alerts when new articles cite this article. Sign up in the box at the topNoteshttp://group.bmj.com/group/rights-licensing/permissionsTo request permissions go to:http://journals.bmj.com/cgi/reprintformTo order reprints go to:http://group.bmj.com/subscribe/To subscribe to BMJ go to:group.bmj.com on August 21, 2015 - Published by http://thorax.bmj.com/Downloaded from 

Once-daily tiotropium and olodaterol fixed-dose combination via the Respimat® improves outcomes versus mono-components in COPD in two 1-year studies

R. Buhl

E. Derom

G. Ferguson

E. Pizzichini

J. Reid

H. Watz

L. Gronke

A. Hamilton

K. Tetzlaff

L. Korducki

H. Huisman

S. Waitere-Wijker

F. Maltais

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P254 Once-daily Tiotropium And Olodaterol Fixed-dose Combination Via The Respimat(R) Improves Outcomes Versus Mono-components In Copd In Two 1-year Studies

https://biblio.ugent.be/publication/6908614/file/6909226.pdf

Once-daily tiotropium and olodaterol fixed-dose combination via the Respimat® improves outcomes versus mono-components in COPD in two 1-year studies

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