Publication year: 2011
Source: Respiratory Medicine, Available online 5 October 2011

Johanna E.A. Williams, Ruth H. Green, Vicki Warrington, Michael C. Steiner, Mike D.L. Morgan, ...

BackgroundThe BODE index has been shown to predict mortality in COPD. The index includes the 6 min walking test as the measure of exercise capacity. The incremental shuttle walking test (ISWT) is an alternative measure of exercise capacity which can be used to prescribe exercise and has been found to correlate well with peak VO2. The objective of the study was to evaluate the incorporation of the ISWT within the BODE index (named thei-BODE) to predict mortality in COPD.MethodsData was analysed from 633 patients with COPD attending pulmonary rehabilitation over an 11 year period, and mortality determined a minimum of one year on from initial assessment. Ani-BODE score was calculated using ISWT(m) then Cox regression analysis evaluated the capacity of the index to predict risk of death.ResultsBMI, ISWT (m), MRC dyspnoea score, pack years and age were all significantly associated with mortality. Cox regression revealed thei-BODE index was an independent and significant predictor of mortality (hazard ratio 1.27 (CI 1.17–1.35),p < 0.001) and Kaplan Meier survival analysis showed each quartile increase in severity ini-BODE score was significantly associated with increased mortality (p < 0.001 by log rank test).ConclusionWe have found thei-BODE index to be an independent predictor of mortality in COPD, even when other strong predictors such as age and pack years are adjusted for. We conclude that the ISWT can be successfully substituted for the 6MWT as an alternative measure of exercise capacity within the BODE index.

Publication year: 2011
Source: Respiratory Medicine, Available online 4 October 2011

Ki Suck Jung, Hye Yun Park, So Young Park, Se Kyu Kim, Young-Kyoon Kim, ...

BackgroundThe combination of tiotropium and fluticasone propionate/salmeterol (FSC) is commonly used to treat chronic obstructive pulmonary disease (COPD), but no study had evaluated the effectiveness of tiotropium plus FSC with 250 μg of fluticasone propionate. Our aim was to assess whether tiotropium (18 μg once daily) plus FSC (250/50 μg twice daily) provides better clinical outcomes compared to tiotropium monotherapy.MethodsIn this 24-week, randomized, open label, multicenter two-arm parallel study, 479 patients received tiotropium plus FSC (n = 237) or tiotropium alone (n = 242).ResultsAfter 24 weeks of treatment, the triple-inhaled treatment group had a significant improvement in pre-bronchodilator FEV1(L) compared to the tiotropium-only group (0.090 L vs. 0.038 L;P = 0.005). Regarding health-related quality of life, the mean change in total score on the St. George’s Respiratory Questionnaire for COPD patients (SGRQ-C) was −6.6 points in the tiotropium plus FSC group, but −1.5 points in the tiotropium-only group (P = 0.001). In the subgroup of GOLD stage II patients with COPD, treatment with tiotropium plus FSC also improved FEV1compared to tiotropium alone (0.088 L vs. 0.030 L;P = 0.011) and improved the total SGRQ-C score than tiotropium alone (−4.5 points vs. −1.0 points, respectively). This triple-inhaled treatment approach did not induce more adverse events, such as pneumonia.ConclusionOver the course of 24 weeks, FSC (250/50 μg twice daily) added to tiotropium provided greater improvement in lung function and quality of life in patients with COPD (FEV1 ≤ 65%) than tiotropium alone.

Publication year: 2011
Source: Respiratory Medicine, Available online 22 October 2011

Giovanna Laurendi, Sonia Mele, Stefano Centanni, Claudio F. Donner, Franco Falcone, ...

The steady increase in incidence of chronic respiratory disease (CRD) now constitutes a serious public health problem. CRDs are often underdiagnosed and many patients are not diagnosed until the CRD is too severe to prevent normal daily activities. The prevention of CRDs and reducing their social and individual impacts means modifying environmental and social factors and improving diagnosis and treatment. Prevention of risk factors (tobacco smoke, allergens, occupational agents, indoor/outdoor air pollution) will significantly impact on morbidity and mortality.The Italian Ministry of Health (MoH) has made respiratory disease prevention a top priority and is implementing a comprehensive strategy with policies against tobacco smoking, indoor/outdoor pollution, obesity, and communicable diseases. Presently these actions are not well coordinated. The Global Alliance against Chronic Respiratory Diseases (GARD), set up by the World Health Organization, envisages national bodies; the GARD initiative in Italy, launched 11/6/2009, represents a great opportunity for the MoH.Its main objective is to promote the development of a coordinated CRD program in Italy. Effective prevention implies setting up a health policy with the support of healthcare professionals and citizen associations at national, regional, and district levels. What is required is a true inter-institutional synergy: respiratory diseases prevention cannot and should not be the responsibility of doctors alone, but must involve politicians/policymakers, as well as the media, local institutions, and schools, etc. GARD could be a significant experience and a great opportunity for Italy to share the GARD vision of a world where all people can breathe freely.

Publication year: 2011
Source: Respiratory Medicine, Available online 26 October 2011

Amir Sharafkhaneh, John G. Southard, Mitchell Goldman, Tom Uryniak, Ubaldo J. Martin

BackgroundTreatment with an inhaled corticosteroid (ICS) and long-acting bronchodilator is recommended for severe/very severe chronic obstructive pulmonary disease (COPD) patients with repeated exacerbations. This randomized, double-blind, double-dummy, parallel-group, 12-month multicenter study evaluated the effect of budesonide/formoterol pressurized metered-dose inhaler (pMDI) on COPD exacerbations.MethodsFollowing a 2-week run-in during which COPD patients aged ≥40 years with an exacerbation history discontinued medications except ICSs, 1219 patients were randomized 1:1:1 to twice-daily budesonide/formoterol pMDI 320/9 μg, budesonide/formoterol pMDI 160/9 μg, or formoterol dry powder inhaler 9 μg. An exacerbation was defined as COPD worsening requiring oral corticosteroids and/or hospitalization. A post hoc analysis, with antibiotic treatment added to the exacerbation definition, was also performed.ResultsBudesonide/formoterol 320/9 and 160/9 reduced exacerbation rates (number per patient-treatment year) by 34.6% and 25.9%, respectively, versus formoterol (p ≤ 0.002).Budesonide/formoterol 320/9 prolonged time to first exacerbation versus formoterol, corresponding to a 21.2% reduction in hazard ratio (0.788 [95% CI: 0.639, 0.972];p = 0.026). Exacerbation rates (number per patient-treatment year) including antibiotic treatment (post hoc analysis) were reduced by 25.9% and 18.7% with budesonide/formoterol 320/9 and 160/9, respectively, versus formoterol (p ≤ 0.023). Both budesonide/formoterol doses were well tolerated with safety profiles similar to formoterol. Pneumonia adverse events occurred in 6.4%, 4.7%, and 2.7% of patients in the budesonide/formoterol 320/9, 160/9, and formoterol groups.ConclusionsOver 12 months, both budesonide/formoterol doses reduced the exacerbation rate (defined with or without antibiotic treatment) versus formoterol. Budesonide/formoterol pMDI is an appropriate treatment for reducing exacerbations in COPD patients with a history of exacerbations. (NCT00419744).