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Tobacco dependence is a common comorbidity in patients with COPD (Chronic Obstructive Pulmonary Disease) that negatively affects the course of the disease. However, clinically relevant improvement in COPD can only be achieved by complete and permanent abstinence. Therefore, abstinence from tobacco use is a central therapeutic concept in smoking patients with COPD and requires specific and targeted treatment.After detailed documentation of smoking behaviour and motivational counseling outlining the risks of smoking, all such patients shall be offered a structured therapy for tobacco cessation. There is high-quality evidence for the effectiveness of a combination therapy of behavioral therapy and medication (to treat the withdrawal syndrome). Due to insufficient data, there is currently no recommendation for the use of e-cigarettes as a primary option for a cessation attempt.Smoking is the most important cause of COPD. Smoking cessation is the most effective and cost-efficient single intervention to reduce the risk of developing and progressing COPD., Competing Interests: SA erhielt Forschungsförderung von Boehringer Ingelheim und Honorar für Referententätigkeit von Boehringer Ingelheim, Novartis, AstraZeneca, GSK, Chiesi, Merini. SA ist Leiter der Task Force Tabakentwöhnung der DGP und Mitglied des ABNR.DK erhielt Forschungsförderung vom Bundesministerium für Gesundheit für die Durchführung der Deutschen Befragung zum Rauchverhalten (DEBRA; DRKS00017157 und DRKS00028054) und für die ABC-II-Studie (RCT zum Training von Hausärzten in der leitliniengerechten Kurzberatung zur Tabakentwöhnung; DRKS00012786).AB erklärt: Förderung durch die Bundeszentrale für gesundheitliche Aufklärung, eigenes Tabakentwöhnungsprogramm (Nichtraucher in sechs Wochen). Mitglied im Vorstand des Wissenschaftlichen Aktionskreises Tabakentwöhnung (WAT) e. V. und der Deutschen Gesellschaft für Suchtforschung und Suchttherapie (DG-Sucht) e. V.AH hielt Vorträge für Orion Pharma.SM erklärt: Pfizer (Vortragshonorar + Beratung); Johnson + Johnson (Honorartätigkeit Workshop + Advisory Board); Leitung Raucherambulanz Chemnitz; Wissenschaftlicher Arbeitskreis Tabakentwöhnung; Mitarbeit S3 LL Alkohol und Tabak.DN erhielt Forschungsunterstützung für Forschungsprojekte des Instituts von EU, DFG, BMBF, BMG, DGUV, BGW, Verwaltungs-BG, Bundesarbeitsministerium, Bayerischen Ministerien, Industrie (MAN, FMG, Siemens, Audi), Versicherungen, ADAC/ÖAMTC, Kliniken, Erzbischöfliches Ordinariat, Caritas. DN erhielt Vortragshonorare von Bristol MyersSquibb, Berlin Chemie, Boehringer Ingelheim, Chiesi, GSK, Mundipharma, Novartis, Hexal, Lilly. DN ist Mitglied eines Advisory Boards von Pfizer zur Rauchentwöhnung. DN ist Vertreter der Deutschen Gesellschaft für Arbeitsmedizin und Umweltmedizin im Aktionsbündnis Nichtrauchen (ABNR).KS erhielt Forschungsförderung von der Deutschen Rentenversicherung Bayern Süd und Honorare für Referententätigkeit von AstraZeneca, GSK, Chiesi, Sanofi Genzyme und Berlin-Chemie.HW erklärt, während der letzten 3 Jahre keine wirtschaftlichen oder persönlichen Verbindungen im oben genannten Sinne zu haben.SS begleitet im Rahmen ihrer Tätigkeit beim ÄZQ die Erstellung von Leitlinien methodisch und organisatorisch., (Thieme. All rights reserved.)

Introduction: Despite being a leading cause of death worldwide, chronic obstructive pulmonary disease (COPD) is underdiagnosed and underprioritized within healthcare systems. Existing healthcare policies should be revisited to include COPD prevention and management as a global priority. Here, we propose and describe health system quality standard position statements that should be implemented as a consistent standard of care for patients with COPD., Methods: A multidisciplinary group of clinicians with expertise in COPD management together with patient advocates from eight countries participated in a quality standards review meeting convened in April 2021. The principal objective was to achieve consensus on global health system priorities to ensure consistent standards of care for COPD. These quality standard position statements were either evidence-based or reflected the combined views of the panel., Results: On the basis of discussions, the experts adopted five quality standard position statements, including the rationale for their inclusion, supporting clinical evidence, and essential criteria for quality metrics. These quality standard position statements emphasize the core elements of COPD care, including (1) diagnosis, (2) adequate patient and caregiver education, (3) access to medical and nonmedical treatments aligned with the latest evidence-based recommendations and appropriate management by a respiratory specialist when required, (4) appropriate management of acute COPD exacerbations, and (5) regular patient and caregiver follow-up for care plan reviews., Conclusions: These practical quality standards may be applicable to and implemented at both local and national levels. While universally applicable to the core elements of appropriate COPD care, they can be adapted to consider differences in healthcare resources and priorities, organizational structure, and care delivery capabilities of individual healthcare systems. We encourage the adoption of these global quality standards by policymakers and healthcare practitioners alike to inform national and regional health system policy revisions to improve the quality and consistency of COPD care worldwide., (© 2022. The Author(s).)

Introduction: Chronic obstructive pulmonary disease (COPD) guidelines recommend reserving triple therapy of inhaled corticosteroid (ICS), long-acting β 2 -agonist (LABA) and long-acting muscarinic antagonist (LAMA) for patients with exacerbations despite dual therapy. However, many patients receive triple therapy without a clear indication. For these patients, it would be useful to know whether ICS can be withdrawn., Methods: DACCORD was a longitudinal, non-interventional 'real-world' study in three cohorts. This manuscript describes the results of Cohort 3, which recruited patients with COPD who had received triple therapy for ≥ 6 months. Prior to entry, each patient's physician decided to continue triple therapy, or switch to a LABA/LAMA; patients were then followed for 12 months, with exacerbations and COPD Assessment Test (CAT) data recorded every 3 months. The primary endpoint was the time until COPD worsening, defined as the occurrence of a moderate/severe exacerbation or clinically relevant CAT worsening., Results: Of the 1192 patients recruited into the study, 967 completed the end-of-study visit and ≥ 2 of the three interim visits, 292 and 675 receiving LABA/LAMA and triple therapy, respectively. Most baseline demographics were similar between the two groups. A lower proportion of patients in the LABA/LAMA group had COPD worsening than with triple therapy (32.5% vs 55.7% at 12 months), with the time to worsening extended in the LABA/LAMA group (hazard ratio 2.004, p < 0.001). In addition, a significantly lower proportion of patients in the LABA/LAMA group exacerbated (18.5% vs 28.7%; p < 0.001), accompanied by a greater improvement from baseline in CAT total score. Overall, fewer patients in the LABA/LAMA group reported adverse events than in the triple therapy group (12.9% vs 15.1%)., Conclusions: These results suggest that in a real world setting physicians are able to identify patients who can be 'stepped down' from triple therapy to LABA/LAMA. Following step down, there was no overall decline in COPD-indeed, some patients had better outcomes., (© 2022. The Author(s).)

To improve acceptance and use of physical training by patients with chronic lung diseases, recommendations for performing lung exercises on an outpatient basis in a group setting are given by experts in physical training, sports therapists and pulmonologists. The evidence-based positive effects of physical training were analyzed for asthma , COPD, interstitial lung diseases, cystic fibrosis, lung carcinoma, and pulmonary hypertension. The requirements for lung exercises in outpatient groups as well as compensation by care providers were given on the basis of legal regulations. Furthermore, the main items of the training units as well as supervision by specially trained group leaders in relation to the severity of the underlying lung disease are described. Finally, aspects of safety of the participating patients are discussed, including the prevention of infection with corona-2-virus., Competing Interests: H. Worth sieht keine Interessenkonflikte zum Inhalt der Empfehlung. Er erhielt Honorare für Beratungen und Vorträge von: AstraZeneca, Berlin Chemie, Chiesi, GSK, Klosterfrau, MSD, Novartis und Omron., (Thieme. All rights reserved.)

Chronic obstructive pulmonary disease (COPD) has a profound impact on people living with the disease and has a high global economic and social burden. Often, people with COPD are undiagnosed, while those diagnosed are undertreated and undereducated on different aspects of COPD care. Although there are many published evidence-based treatment guidelines from different expert groups and societies, they are frequently not adhered to, which results in significant gaps in care. In particular, 'flare-ups' (known as exacerbations of COPD), which accelerate disease progression, are often under-reported, despite guidelines recommending an escalation of maintenance treatment to prevent subsequent flare-ups. Management of COPD should be proactive to prevent worsening of symptoms and to reduce the risk of future flare-ups and premature death, rather than a secondary reaction to a worsening health status. Key to this is patient access to accurate diagnosis, effective treatment and specialist care, which can vary widely due to socioeconomic differences, geographical locations and poor guideline implementation. In addition, the stigma associated with COPD can act as a barrier, which can result in people being reluctant to access treatment or clinicians being nihilistic. As global patient advocates, we have co-developed this patient charter to set a standard of care that people living with COPD should expect, raising awareness and understanding of the causes and consequences of COPD as well as the potential to improve patient care. Patients with COPD should be empowered to live the highest quality of life possible with the least number of flare-ups. We set out six principles in line with current COPD guideline recommendations, that should be implemented by governments, healthcare providers, policymakers, lung health industry partners and patients/caregivers to drive meaningful change in COPD care.

Long-term oxygen therapy is of great importance both for reducing mortality and for improving performance in patients with chronic lung diseases. The prerequisites for Long-term oxygen therapy are adequate diagnostics and clearly defined indication. A causal distinction into chronic hypoxaemic and hypercapnic respiratory failure is reasonable, from which the differential indication for non-invasive ventilation results.The revised guideline covers the diagnostics and indication of chronic lung and heart diseases, the role of oxygen in terminal illness and gives a detailed description of available oxygen devices. The guideline is intended to help avoid undersupply, oversupply and false prescriptions. Furthermore, the chapter "Postacute Oxygen Therapy" discusses the procedure, relevant in everyday life, but not yet clearly defined, for prescribing oxygen therapy for the home at the end of an inpatient stay. Another important point, the correct prescription of mobile oxygen systems, is also presented in the guideline. This document is a revised version of the guideline for longterm oxygen therapy and replaces the version of 2008., Competing Interests: Eine Übersicht der Interessenkonflikte findet sich im Internet unter http://awmf.org; AWMF-Registriernummer: 20-002., (Thieme. All rights reserved.)

Purpose: A number of analyses have shown the immediate impact of COPD exacerbations on health status. However, none evaluated the long-term correlation between health status and the occurrence of exacerbations., Methods: DACCORD is an observational study in patients with COPD recruited across Germany following initiation or change in COPD maintenance medication. Data collected include COPD Assessment Test (CAT) total score on entry and after 1 and 2 years, and the occurrence of exacerbations. We analysed the correlation between change from baseline in CAT total score and exacerbations, after excluding patients who exacerbated during the quarter immediately prior to the CAT assessment of interest., Results: The initial correlation analysis was performed in 6075 patients, 28% with ≥ 1 exacerbation over the 2-year follow-up, and 58% with a clinically relevant CAT improvement. There was a significant correlation between exacerbations over 2 years and CAT change from baseline at Year 2 (p = 0.0041). The Spearman's correlation coefficient was 0.03711, indicating very weak correlation-potentially driven by the high proportion of non-exacerbating patients. In a subsequent logistic regression, the probability of experiencing frequent (≥ 2 per year) or severe exacerbations was higher in patients with worsening in CAT total score (p < 0.001). However, the probability of a patient exacerbating in Year 1 or Year 2 did not correlate with CAT change., Conclusions: In this population (initiating or changing maintenance COPD medication), patients with frequent or severe exacerbations had a long-term worsening in health status (beyond the acute effect of an exacerbation) compared with patients who do not exacerbate.

The mucolytic monoterpene 1,8-cineole (eucalyptol), the major constituent of eucalyptus species, is well known for its anti-inflammatory, antioxidant, bronchodilatory, antiviral and antimicrobial effects. The main protective antiviral, anti-inflammatory and mucolytic mechanisms of 1,8-cineole are the induction of interferon regulatory factor 3 (IRF3), the control of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) along with decreasing mucin genes (MUC2, MUC19). In normal human monocytes direct inhibition was shown of reactive oxygen species (ROS)-mediated mucus hypersecretion and of steroid resistence inducing superoxides (O 2 ) and pro-inflammatory hydrogen peroxides (H ·- ) and pro-inflammatory hydrogen peroxides (H 2 O 2 into H 2 ·- into H 2 O 2 . By inhibition of NF-κB, 1,8-cineole, at relevant plasma concentrations (1.5 µg/ml), strongly and significantly inhibited in normal human monocyte lipopolysaccharide (LPS)-stimulated cytokines relevant for exacerbation (tumour necrosis factor alpha (TNFα), interleukin (IL)-1β and systemic inflammation (IL-6, IL-8). Infectious agents and environmental noxa have access via TNFα and IL-1β to the immune system with induction of bronchitis complaints and exacerbations of chronic obstructive pulmonary disease (COPD), asthma and asthma-COPD overlap. In lymphocytes from healthy human donors 1,8-cineole inhibited TNFα, IL-1β, IL-4 and IL-5 and demonstrated for the first time control of Th1/2-type inflammation. 1,8-Cineole at relevant plasma levels increased additively in vitro the efficacy of inhaled guideline medications of budesonide (BUD) and budesonide + formoterol ,and preliminary data also showed increased efficacy of long-acting muscarinic receptor antagonist (LAMA)-mediated cytokine inhibition in vitro. On the basis of the preclinical data, earlier randomised controlled studies with adjunctive therapy of 1,8-cineole (3 × 200 mg/day) for 6 months showed improvement of uncontrolled asthma by significant improvement of lung function, nocturnal asthma and quality of life scores and in COPD decrease of exacerbations (- 38.5%) (during wintertime). This review reports an update with reference to the literature of 1,8-cineole, also as adjunctive therapy, as a therapeutic agent for the protection and control of inflammatory airway diseases.

Introduction:  Inhalative treatments with metered dose aerosols and dry powder inhalers are the backbone of the pharmacotherapy for asthma and COPD. In the last decade many new and generic inhalative bronchodilators were launched at the German market, both monotherapies and fixed dose double bronchodilator (LABA/LAMA, beta adrenergic and antimuscarinic) or LABA and inhaled corticosteroid (ICS) and triple (LABA/LAMA/ICS) combinations. According to two surveys in 2015 among respiratory physicians we expected a high proportion of patients receiving duplicate prescriptions, e. g. a fixed dose new LABA/LAMA combination in addition to an existing ICS/LABA fixed dose combination., Methodology:  We searched the database of a large mail order pharmacy (DocMorris) to identify duplicate prescriptions of inhalative drugs for a patient by the same or by two or more different physicians during a 3 months period., Results:  Unexpectedly, we found as little as around 1 % duplicate prescriptions for the same patient. Duplicate prescriptions involving combination products were found to be much more common than duplicate prescriptions of different mono-products. Irrespective the low percentage number of all prescriptions we saw in just one large mail order pharmacy several thousands of erroneous prescriptions., Conclusion:  At least in the setting of this mail order pharmacy duplicate (i. e. contraindicated and potentially dangerous) prescriptions are relatively rare. Prescribers and pharmacists should be aware of the issue of duplicates - especially when prescribing or filling prescriptions with combination products., Competing Interests: According to this paper the authors PK and HW declare no conflict of interest.FG, JS and CF are employees of DocMorris, Heerlen.UB is Executive manager of the German Airways League., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: No observational studies have evaluated the "real-world" effectiveness of dual bronchodilation comprising a long-acting β 2 -agonist plus a long-acting muscarinic antagonist vs that of triple therapy (long-acting β 2 -agonist plus long-acting muscarinic antagonist plus inhaled corticosteroid) in COPD., Materials and Methods: DACCORD is a non-interventional, observational clinical study that recruited patients following COPD maintenance therapy initiation or change in maintenance therapy between or within therapeutic class. Given the non-interventional nature of the study, the decision to initiate or change medication had to be made by the patients' physicians prior to inclusion in DACCORD. We used a matched-pairs analysis to compare disease progression in two patient groups: those receiving dual bronchodilation vs those receiving triple therapy (each group n=1,046)., Results: In two subgroups of patients matched according to a broad range of demographic and disease characteristics, over 1 year, fewer patients receiving dual bronchodilation exacerbated than those receiving triple therapy (15.5% vs 26.6%; P <0.001), with a greater improvement from baseline in COPD Assessment Test total score at 1 year (mean±SD -2.9±5.8 vs -1.4±5.5; P <0.001). When analyzed according to prior therapy, the highest rate of exacerbations was in patients on triple therapy prior to the study who remained on triple therapy. Those changing from mono-bronchodilator to dual bronchodilation had the greatest COPD Assessment Test total score improvement., Conclusion: In this "real-life" cohort of patients with COPD, most of whom had not exacerbated in the 6 months prior to entry, triple therapy did not seem to improve outcomes compared with dual bronchodilation in terms of either exacerbations or health status. Our analyses clearly demonstrate the potential impact of prior medication on study results, something that should be taken into account when interpreting the results even of controlled clinical trials., Competing Interests: Disclosure Dr Buhl reports personal fees from AstraZeneca, Chiesi, Teva, and Cipla, grants and personal fees from Boehringer Ingelheim, Novartis, and Roche, and grants from GlaxoSmithKline, all of which are outside the submitted work. Dr Criée reports personal fees from Chiesi, Boehringer Ingelheim, Novartis, Menarini, and Takeda, all of which are outside the submitted work. Dr Kardos reports personal fees from Novartis, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Menarini, and Takeda, all of which are outside the submitted work. Dr Vogelmeier reports personal fees from Almirall, Cipla, Berlin Chemie/Menarini, CSL Behring, and Teva, grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Mundipharma, Novartis, and Takeda, and grants from the German Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD (ASCONET), Bayer Schering Pharma AG, MSD, and Pfizer, all of which are outside the submitted work. Dr Kostikas is employed by, and is a stockholder in Novartis, the sponsor of the study. Outside the submitted work, he reports personal fees from Astra Zeneca, Boehringer Ingelheim, Chiesi, ELPEN, Novartis, and Takeda. Dr Lossi is employed by Novartis, the sponsor of the study. Dr Worth reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Klosterfrau, Menarini, Novartis, and Takeda, all of which are outside the submitted work. The authors report no other conflicts of interest in this work.

This document is a revision of the guideline for diagnosis and treatment of COPD that replaces the version from 2007. A multitude of recent reports regarding risk factors, diagnosis, assessment, prevention and pharmacological as well as non-pharmacological treatment options made a major revision mandatory. The new guideline is based on the GOLD document taking into account specifics in Germany and Austria., Competing Interests: Eine Übersicht der Interessenkonflikte findet sich im Internet unter http://www.awmf.org; AWMF-Registernummer 020-006., (© Georg Thieme Verlag KG Stuttgart · New York.)

Introduction: The 2017 update to the Global Initiative for Obstructive Lung Disease (GOLD) strategy document includes recommendations for treatment intensification or step-down in chronic obstructive pulmonary disease (COPD), although recognises that limited supporting information is available. DACCORD is an ongoing observational, non-interventional study, recruiting patients following COPD maintenance treatment change or initiation, a subset of whom were receiving a long-acting β 2 -agonist (LABA) plus a long-acting muscarinic antagonist (LAMA) fixed-dose combination (FDC) on entry. Since there were no requirements in terms of prior medication (and no washout before commencing LABA/LAMA FDC), this provides an opportunity to generate 'real world' data to test the GOLD 2017 recommendations., Methods: To reduce heterogeneity, the current analyses include patients receiving indacaterol/glycopyrronium at baseline, and who, prior to the study, were receiving no COPD maintenance medication ('none'), LABA or LAMA monotherapy ('mono'), LABA plus inhaled corticosteroid (ICS; 'LABA/ICS'), or triple therapy ('triple'). At the baseline visit, data collected included: demographic and disease characteristics; COPD Assessment Test (CAT); and exacerbations in the 6 months prior to entry. At 3, 6, 9 and 12 months data on exacerbations were collected, with CAT recorded at 3 and 12 months., Results: A total of 2724 patients were included in the baseline analyses: 795, 954, 598 and 377 in the 'none', 'mono', 'LABA/ICS' and 'triple' subgroups, respectively. There were no clinically relevant differences in baseline demographics between the four groups. In terms of disease characteristics, the 'triple' group had the highest proportion of patients with a disease duration of more than 1 year since diagnosis and with severe/very severe airflow limitation, but a similar percentage of non-exacerbators compared to the 'none' group. Over the 1-year follow-up, the majority of patients in all four subgroups did not exacerbate (exacerbation rates 0.16, 0.19, 0.21, and 0.26 in the 'none', 'mono', 'LABA/ICS' and 'triple' groups, respectively). At 12 months, 61.4%, 65.0%, 71.0% and 52.4% of patients had a clinically relevant improvement in CAT score., Conclusions: Overall, the results support the GOLD recommendations in suggesting that a switch from a mono-bronchodilator or LABA plus ICS to LABA/LAMA FDC is a valid treatment option for patients with COPD. The results also validate the use of a LABA/LAMA FDC as initial maintenance treatment for COPD, and provide first 'real world' evidence to support the newly added 'step down' recommendation (from triple to LABA/LAMA FDC)., (Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: DACCORD is an observational, non-interventional study being conducted in German primary and secondary care centres. The study aims to describe the impact of disease (including exacerbations) and treatments over 2 years on 'real-life' patients with chronic obstructive pulmonary disease (COPD)., Materials and Methods: Patients had a clinical and spirometry diagnosis of COPD, were aged ≥40 years and, on recruitment, were initiating or changing COPD maintenance medication. The only exclusion criteria were asthma and randomised clinical trial participation. Exacerbations data were collected every 3 months. COPD medication, COPD Assessment Test (CAT) and forced expiratory volume in 1 s (FEV 1 ) were recorded at baseline and after 1 and 2 years., Results: A total of 6122 patients were recruited, 3137 (51.2%) of whom completed the 2-year visit. The mean age of these patients was 65.6 years, 59% were male, 69% had mild or moderate airflow limitation, and their mean COPD Assessment Test (CAT) total score was 20.3. Overall, there was a trend towards decreasing COPD exacerbation rates over the 2-year follow-up period, with rates of 0.390 during Year 1 and 0.347 during Year 2. Rates were lower in patients with no exacerbation during the 6 months prior to entry (0.263 and 0.251 during Years 1 and 2, respectively), with 51.6% of patients having no exacerbation during the 6 months prior to entry and over the 2-year follow-up. Approximately 50% of the overall population experienced a clinically relevant improvement from baseline in CAT total score at Year 1 and 2. When assessed by treatment class (or classes), persistence to medication was high (77.8% in Year 1 and 71.4% in Year 2)., Conclusions: Overall, the 2-year follow-up data from DACCORD suggest that for most patients with COPD exacerbations are a rare event. For the majority of patients, the focus should be on managing symptoms, and the impact that these symptoms have on their daily lives. Even for those patients who do exacerbate, although prevention of exacerbations is an important factor, management of symptoms should be a key consideration. DACCORD also suggests that COPD disease progression is not inevitable - providing patients are receiving pharmacological treatment., (Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Many patients with chronic obstructive pulmonary disease (COPD) receive inhaled corticosteroids (ICSs) without a clear indication, and thus, the impact of ICS withdrawal on disease control is of great interest. DACCORD is a prospective, noninterventional 2-year study in the primary and secondary care throughout Germany. A subgroup of patients were taking ICS prior to entry - 1,022 patients continued to receive ICS for 2 years; physicians withdrew ICS on entry in 236 patients. Data from these two subgroups were analyzed to evaluate the impact of ICS withdrawal. Patients aged ≥40 years with COPD, initiating or changing COPD maintenance medication were recruited, excluding patients with asthma. Demographic and disease characteristics, prescribed COPD medication, COPD Assessment Test, exacerbations, and lung function were recorded. There were few differences in baseline characteristics; ICS withdrawn patients had shorter disease duration and better lung function, with 74.2% of ICS withdrawn patients not exacerbating, compared with 70.7% ICS-continued patients. During Year 1, exacerbation rates were 0.414 in the withdrawn group and 0.433 in the continued group. COPD Assessment Test total score improved from baseline in both groups. These data suggest that ICS withdrawal is possible with no increased risk of exacerbations in patients with COPD managed in the primary and secondary care., Competing Interests: Disclosure CV reports personal fees from Almirall, AstraZeneca, Berlin-Chemie – Menarini, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mundipharma, Novartis, and Takeda, and grants and personal fees from Grifols. HW reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Klosterfrau, Menarini, Novartis, and Takeda. RB reports personal fees from AstraZeneca, Chiesi, GlaxoSmithKline, and Teva, and grants and personal fees from Boehringer Ingelheim, Novartis, and Roche. C-PC reports personal fees from Boehringer Ingelheim, Chiesi, GSK, Novartis, Takeda, and Berlin-Chemie. NSL is employed at Novartis Pharma GmbH, Nürnberg, Germany, the sponsor of the study. CM is employed at Novartis Pharma GmbH, Nürnberg, Germany, the sponsor of the study. PK reports personal fees from Novartis, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Menarini, and Takeda. The authors report no other conflicts of interest in this work.

This observational study assessed the relationship between nighttime, early-morning and daytime chronic obstructive pulmonary disease (COPD) symptoms and exacerbations and healthcare resource use. COPD symptoms were assessed at baseline in patients with stable COPD using a standardised questionnaire during routine clinical visits. Information was recorded on exacerbations and healthcare resource use during the year before baseline and during a 6-month follow-up period. The main objective of the analysis was to determine the predictive nature of current symptoms for future exacerbations and healthcare resource use. 727 patients were eligible (65.8% male, mean age: 67.2 years, % predicted forced expiratory volume in 1 second: 52.8%); 698 patients (96.0%) provided information after 6 months. Symptoms in any part of the day were associated with a prior history of exacerbations (all p < 0.05) and nighttime and early-morning symptoms were associated with the frequency of primary care visits in the year before baseline (both p < 0.01). During follow-up, patients with baseline symptoms during any part of the 24-hour day had more exacerbations than patients with no symptoms in each period (all p < 0.05); there was also an association between 24-hour symptoms and the frequency of primary care visits (all p ≤ 0.01). Although there was a significant association between early-morning and daytime symptoms and exacerbations during follow-up (both p < 0.01), significance was not maintained when adjusted for potential confounders. Prior exacerbations were most strongly associated with future risk of exacerbation. The results suggest 24-hour COPD symptoms do not independently predict future exacerbation risk.

Introduction: Randomized interventional trials generally recruit highly selected patients. In contrast, long-term, noninterventional studies can reflect standard of care of real-life populations. DACCORD (Die ambulante Versorgung mit langwirksamen Bronchodilatatoren: COPD-Register in Deutschland [Outpatient Care With Long-Acting Bronchodilators: COPD Registry in Germany]) is an ongoing observational study, conducted in primary and secondary care in Germany, aiming to describe the impact of disease and treatments on real-life patients with chronic obstructive pulmonary disease (COPD)., Methods: Patients had a clinical and spirometry diagnosis of COPD, were aged ≥40 years, and were initiating or changing COPD maintenance medication. The only exclusion criteria were asthma and participation in a randomized clinical trial. Exacerbation data were collected every 3 months. COPD medication, COPD Assessment Test, and forced expiratory volume in 1 second (FEV1) were recorded at the end of the 1 year period., Results: In the 6 months prior to baseline, 26.5% of the 3,974 patients experienced ≥1 exacerbation, compared with 26.1% over the 1-year follow-up (annualized rate 0.384). Importantly, only previous exacerbations and not poor lung function alone predicted an increased exacerbation risk. There was a general shift to lower disease severity from baseline to 1 year, predominantly as a consequence of a lower proportion of patients considered at high risk due to exacerbations. COPD Assessment Test mean change from baseline was -1.9, with 48.9% of patients reporting a clinically relevant improvement. Overall persistence to medication was high, with 77.2% of patients still receiving the same class of medication at 1 year., Conclusion: DACCORD suggests that in clinical practice, the large majority of COPD patients are symptomatic but seldom exacerbate and that widely used tools and treatment recommendations do not reflect this fully.

Introduction: DACCORD is an ongoing, longitudinal, non-interventional study within the German COPD National Prospective Registry. This manuscript describes the baseline characteristics of the first 5924 participants, recruited between November 2012 and November 2013., Methods: The main inclusion criteria are a physician diagnosis of COPD, age ≥40 years, and initiating or changing COPD maintenance medication. Data collected included: Demographic and disease characteristics; prescribed medication; symptoms; COPD Assessment Test (CAT); modified Medical Research Council dyspnoea score (mMRC); exacerbations; comorbidities; and forced expiratory volume in 1 s (FEV1)., Results: Approximately 60% of the population are male, with mean age of 65.7 years and FEV1 61.6% predicted. On entry to the study the majority of patients reported symptoms, most commonly exertional dyspnoea (85.9%) and cough (65.7%). According to GOLD 2010, 48.6% of patients were classified as GOLD II. GOLD 2011 classification was influenced by the symptoms criterion: 43.7 and 45.3% of patients were classified as GOLD B or D using CAT, compared with 26.4 and 34.0%, respectively, using mMRC. The majority of patients were receiving a LAMA-containing regimen, with 39.4% overall receiving ICS. A total of 78.3% of patients reported at least one comorbidity, most commonly cardiovascular., Conclusion: In conclusion, DACCORD is a large, prospective, non-interventional study that provides an informative and intriguing picture of the typical COPD patient in Germany., (Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.)

The main complaint of patients with chronic obstructive pulmonary disease (COPD) is shortness of breath with exercise, that is usually progressive. The principal mechanism that explains this symptom is the development of lung hyperinflation (LH) which is defined by an increase of functional residual capacity (FRC) above predicted values. Patients with COPD may develop static LH (sLH) because of destruction of pulmonary parenchyma and loss of elastic recoil. In addition, dynamic LH (dLH) develops when patients with COPD breathe in before achieving a full exhalation and, as a consequence, air is trapped within the lungs with each further breath. Dynamic LH may also occur at rest but it becomes clinically relevant during exercise and exacerbation. Lung hyperinflation may have an impact beyond the lungs and the effects of LH on cardiovascular function have been extensively analysed. The importance of LH makes its identification and measurement crucial. The demonstration of LH in COPD leads to the adoption of strategies to minimise its impact on the daily activities of patients. Several strategies reduce the impact of LH; the use of long-acting bronchodilators has been shown to reduce LH and improve exercise capacity. Non pharmacologic interventions have also been demonstrated to be useful. This article describes the pathophysiology of LH, its impact on the lungs and beyond and reviews the strategies that improve LH in COPD., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

The positive influence of regular physical training on the course of many chronic diseases in different fields is well documented. Especially for obstructive respiratory diseases the benefit of lung exercise is convincing. An overview will be given in this work how lung exercise can be an effective form of therapy for pulmonary diseases. Actually the evidence of the efficacy of physical activity is particularly overwhelming in obstructive pulmonary diseases. Several clinical trials showed an enhancement in endurance and exercise capacity, quality of life and a decrease of dyspnea and disease-related symptoms. However in comparison to other disease groups, the benefits and awareness and therefore a widespread dissemination is still insufficient. Regular physical activity is an important, effective and also cost-effective component of the therapy of respiratory diseases and is sometimes even superior to a drug therapy. Enough reason to share this kind of therapy with our patients with pulmonary diseases., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: A variety of large randomized controlled trials (RCT's) evaluating pharmacotherapy in chronic obstructive pulmonary disease (COPD) patients does exist. One of the drugs that has been tested is the new long-acting anticholinergic glycopyrronium bromide., Methods: As the generalizability of results from RCT's is questionable we designed a longitudinal, prospective non-interventional study (DACCORD) of two years duration plus two years extension with at least 6000 participants in approximately 500 primary and secondary care practices in Germany (within the new established COPD National Prospective Registry), to assess patient reported outcomes (PRO's), lung function, adherence and drug safety. To circumvent the hurdle of inappropriate COPD diagnosis in a non-interventional trial, patients have to fulfill the inclusion criteria of the COPD disease management program (DMP) of the German statutory health insurances. Patient management should follow the German national COPD guidelines, which are based on Global Initiative for Chronic Obstructive Lung Disease 2007 (GOLD) report. Labels of prescribed drugs should also be taken into account. Patients received treatment as part of their standard care: at the discretion of the investigator patients were included in one of two arms. A: standard care with glycopyrronium containing regimen, and arm B: standard care without glycopyrronium., Discussion: For 2016 we expect important results regarding longitudinal development of PRO's including exacerbations, lung function, adherence and side effects. We also investigate applicability of the new GOLD staging system in usual care. Data on diagnostic and treatment modalities in current German primary and secondary care, as well as pharmaco-economic data will be generated., Trial Registration: 1. German Register for non-interventional studies: http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb . 2. EMA EnCePP http://www.encepp.eu/ .

Background: Few studies have investigated the 24-hour symptom profile in patients with COPD or how symptoms during the 24-hour day are inter-related. This observational study assessed the prevalence, severity and relationship between night-time, early morning and daytime COPD symptoms and explored the relationship between 24-hour symptoms and other patient-reported outcomes., Methods: The study enrolled patients with stable COPD in clinical practice. Baseline night-time, early morning and daytime symptoms (symptom questionnaire), severity of airflow obstruction (FEV1), dyspnoea (modified Medical Research Council Dyspnoea Scale), health status (COPD Assessment Test), anxiety and depression levels (Hospital Anxiety and Depression Scale), sleep quality (COPD and Asthma Sleep Impact Scale) and physical activity level (sedentary, moderately active or active) were recorded., Results: The full analysis set included 727 patients: 65.8% male, mean ± standard deviation age 67.2 ± 8.8 years, % predicted FEV1 52.8 ± 20.5%. In each part of the 24-hour day, >60% of patients reported experiencing ≥1 symptom in the week before baseline. Symptoms were more common in the early morning and daytime versus night-time (81.4%, 82.7% and 63.0%, respectively). Symptom severity was comparable for each period assessed. Overall, in the week before baseline, 56.7% of patients had symptoms throughout the whole 24-hour day (3 parts of the day); 79.9% had symptoms in ≥2 parts of the 24-hour day. Symptoms during each part of the day were inter-related, irrespective of disease severity (all p < 0.001). Early morning and daytime symptoms were associated with the severity of airflow obstruction (p < 0.05 for both). Night-time, early morning and daytime symptoms were all associated with worse dyspnoea, health status and sleep quality, and higher anxiety and depression levels (all p < 0.001 versus patients without symptoms in each corresponding period). In each part of the 24-hour day, there was also an association between symptoms and a patient's physical activity level (p < 0.05 for each period)., Conclusions: More than half of patients experienced COPD symptoms throughout the whole 24-hour day. There was a significant relationship between night-time, early morning and daytime symptoms. In each period, symptoms were associated with worse patient-reported outcomes, suggesting that improving 24-hour symptoms should be an important consideration in the management of COPD.

We evaluated the effect of QVA149, a dual bronchodilator combining indacaterol and glycopyrronium, on direct patient-reported dyspnoea in patients with moderate-to-severe chronic obstructive pulmonary disease. In this multicentre, blinded, double-dummy, three-period crossover study, 247 patients were randomised to once-daily QVA149 110/50 μg, placebo or tiotropium 18 μg. Superiority of QVA149 versus placebo (primary objective) and tiotropium (secondary objective) was assessed for improvement in dyspnoea via the self-administered computerised (SAC) version of the Baseline and Transition Dyspnoea Index after 6 weeks. Secondary end-points included lung function, rescue medication use and safety. After 6 weeks, the SAC Transition Dyspnoea Index total score was significantly higher with QVA149 versus placebo (least squares mean (LSM) treatment difference 1.37, p<0.001) and tiotropium (LSM treatment difference 0.49, p=0.021). QVA149 provided significant improvements in lung function, with higher forced expiratory volume in 1 s area under the curve from 0-4 h post-dose versus placebo and tiotropium at day 1 and week 6 (all p<0.001). Rescue medication use was significantly lower with QVA149 versus placebo (p<0.001) and tiotropium (p=0.002). All treatments were well tolerated. Once-daily QVA149 provided superior improvements in patient-reported dyspnoea and lung function versus placebo and tiotropium. These benefits were associated with improvements in other symptoms and reduced use of rescue medication., (©ERS 2014.)

Chronic obstructive pulmonary disease (COPD) is a leading cause of death worldwide. Cigarette smoking is the main cause of COPD. Quitting smoking is thus the most effective treatment strategy and central in COPD prevention. A number of guidelines on prevention, diagnosis, therapy and rehabilitation of COPD have been published. To help implementing and standardizing smoking cessation in COPD a guideline was published 2008 in Germany focusing on this complex issue. The present guideline is an update of the 2008 guideline and has a high grade of evidence (S3 according to the AWMF; Arbeitsgemeinschaft wissenschaftlicher medizinischer Fachgesellschaften). The guideline gives comprehensive and practical information on how to integrate smoking cessation as an central part of COPD therapy., (© Georg Thieme Verlag KG Stuttgart · New York.)

This overview presents data that take advantage of a new step of insight into COPD. Large population-based retrospective studies and intensively investigated prospective cohorts are two important sources of knowledge that have been recently developed. One of the contributions introduces the German COSYCONET which is on its way shortly after the American ECLIPSE cohort. The vast amount of new data has also contributed to some corrections of the recommendations of the international GOLD committee. Clinically important are the waiver of the reversibility test for the diagnosis of COPD, the inclusion of sympotom scores to evaluate quality of life and the estimation of exacerbations. The COPD types I through IV were originally the result of expert opinion, but their impact on prognosis has recently been evaluated empirically.The top issues of the expert meeting were cardiovascular aspects of COPD. Besides the comorbidity of two significant chronic diseases, it became clear that cardiovascular events have an outstanding significance for COPD patients. Inversely, advanced COPD is an important risk factor in cardiac and vascular diseases. The mutual influence of both disease entities does not only affect the long term progression but also the outcome of acute events like myocardial infarction and COPD exacerbation. The following contributions investigate the topic with regard to epidemiology, the biology of vessels, and especially with regard to acute COPD exacerbations and pharmakotherapy. Recent evidence enables a fresh view on the cardiovascular toxicity of COPD medication and on possible protective effects of cardiovascular drugs (i.e. statins and ß-receptor antagonists) for patients with COPD., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: As COPD patients commonly suffer cardio- and cerebrovascular (CCV) co-morbidities, our purpose was to establish the CCV safety profile of indacaterol, a novel, inhaled, long-acting β(2)-agonist for COPD., Methods: The indacaterol clinical trial database comprised 4635 patients with moderate-to-severe COPD enrolled into studies of ≥6 months' duration treated with indacaterol, placebo or other bronchodilators (formoterol, salmeterol, tiotropium). Adverse events (AEs) were analysed overall and according to Anti-Platelet Trialists' Collaboration (APTC) criteria and baseline cardiovascular risk factors. A subset of patients had Holter monitoring., Results: Compared with placebo, indacaterol did not increase the risk of CCV AEs; relative risks were not significantly different for indacaterol versus other treatments. In all treatment groups, including placebo, most CCV AEs occurred in patients with pre-existing cardiovascular risk factors. The risk of APTC events (e.g. myocardial infarction, stroke, cardiovascular-related death) was not significantly increased for indacaterol versus placebo. The incidence of notable QTc interval increases >60 ms was low with all active treatments (0-0.5%, versus 0.3% with placebo). Holter monitoring in the subset of patients receiving indacaterol, tiotropium or placebo showed no clinically relevant effect of indacaterol or tiotropium relative to placebo on the development of arrhythmias. The number of deaths adjusted for exposure was lower with all active treatments than with placebo, with a trend to reduced risk with indacaterol (relative risk 0.30, p = 0.054)., Conclusion: The overall CCV safety profile of indacaterol was similar to placebo and comparable with other long-acting bronchodilators, providing reassurance for regular long-term use of indacaterol in COPD. Data for this analysis were pooled from three studies, registered at ClinicalTrials.gov as: NCT00393458, NCT00463567 and NCT00567996., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

Background: Breathlessness and exercise intolerance frequently impact the daily life of patients with COPD., Methods: This double-blind, multicentre, three-period crossover study randomised 111 patients with COPD (mean age 64 years, mean FEV(1) 38% of predicted normal) to budesonide/formoterol 320/9 microg, formoterol 9 microg or placebo, twice daily for 1 week, following a 1-week run-in period with 1-week wash-out between treatments. Terbutaline (0.5 mg/dose) was used as needed. The primary efficacy variable was exercise endurance time (EET) at 75% peak work capacity with cycle ergometry assessed 1 h post-morning dose., Results: Budesonide/formoterol prolonged EET 1 h post-morning dose versus formoterol by 69 s (P < 0.005) and placebo by 105 s (P < 0.0001) and improved inspiratory capacity (IC) at isotime during exercise versus formoterol by 8% (P = 0.011) and placebo by 16% (P < 0.0001). Borg score at isotime was reduced by 0.48 (P = 0.12) and 0.78 (P = 0.014) compared with formoterol and placebo, respectively. At the repeated cycle test 6 h after morning dose, the effect on EET still favoured budesonide/formoterol over formoterol and placebo, while the isotime IC and Borg score were similar but better than placebo for the active study drugs. Budesonide/formoterol and formoterol improved health status (St George's Respiratory Questionnaire total score: mean difference versus placebo -2.4 and -2.2, respectively). All treatments were well tolerated., Conclusions: Budesonide/formoterol resulted in a significant improvement in endurance time 1 h after the last morning dose in a 1-week treatment period versus formoterol and placebo. This study demonstrates, for the first time, the benefit of inhaled corticosteroids in addition to long-acting beta(2)-agonists on exercise tolerance in COPD patients. www.clinicaltrials.gov registration number: NCT00489853.

The term COPD which comprises chronic obstructive bronchitis and emphysema, was first defined in 1964. Key milestones to the understanding of the etiopathology of COPD were the discovery of the association between tobacco consumption and the development of chronic bronchitis as well as the discovery of the role of a protease-antiprotease imbalance leading to emphysema. The assessment of functional impairement of patients with COPD was established in the 1960s and the quantification and localisation was predominantly explored in the 1980s. The management of COPD comprises preventative measures (e.g. smoking cessation, vaccination against influenza, reduction of occupation hazards), medical therapies (bronchodilators, corticosteroids), non-pharmacological therapies (exercise training, patient education, physiotherapy) as well as surgical options. The prevention and efficiency management of exacerbations are of particular importance. Optimal management of COPD has to take impact of the disease on other organs into account. The future of COPD-related research lies in the development of international and national networks to facilitate the analysis of genetic factors on the pathology of COPD., (Copyright Georg Thieme Verlag KG Stuttgart . New York.)

Rationale: Indacaterol is the first once-daily, long-acting inhaled beta(2)-agonist bronchodilator studied in patients with chronic obstructive pulmonary disease (COPD)., Objectives: To demonstrate greater efficacy of indacaterol versus placebo on FEV(1) at 24 hours post dose (trough) after 12 weeks, to compare efficacy with placebo and tiotropium, and to evaluate safety and tolerability over 26 weeks., Measurements: Patients with moderate-to-severe COPD were randomized to double-blind indacaterol 150 or 300 microg or placebo, or open-label tiotropium 18 microg, all once daily, for 26 weeks. The primary efficacy outcome was trough FEV(1) at 12 weeks. Additional analyses (not adjusted for multiplicity) included transition dyspnea index (TDI), health status (St George's Respiratory Questionnaire [SGRQ]), and exacerbations. Serum potassium, blood glucose, and QTc interval were measured., Results: A total of 1,683 patients (age, 63.3 yr; post-bronchodilator FEV(1), 56% predicted; FEV(1)/FVC, 0.53) were randomized to the four treatment arms. Trough FEV(1) at Week 12 increased versus placebo by 180 ml with both indacaterol doses and by 140 ml with tiotropium (all P < 0.001 vs. placebo). At Week 26, for indacaterol 150/300 microg, respectively, versus placebo, TDI increased (1.00/1.18, P < 0.001) and SGRQ total score decreased (-3.3/-2.4, P < 0.01); corresponding results with tiotropium were 0.87 (P < 0.001) for TDI and (-1.0, P = not significant) for SGRQ total score. The incidence of adverse events, low serum potassium, high blood glucose, and prolonged QTc interval was similar across treatments., Conclusions: Indacaterol was an effective once-daily bronchodilator and was at least as effective as tiotropium in improving clinical outcomes for patients with COPD. Clinical trial registered with clinicaltrials.gov (NCT 00463567).

The treatment of chronic obstructive pulmonary disease (COPD) with or without emphysema includes prevention, management of exacerbation and of stable disease. Smoking cessation is the most important intervention to reduce the risk of developing COPD and stop its progression. Bronchodilator medications and inhaled glucocorticosteroids are given to reduce symptoms and exacerbations in long-term medical therapy. Pulmonary rehabilitation including exercise training and patient education improves symptoms and morbidity. The management of exacerbations includes intensified treatments with bronchodilators, systemic corticosteroids for 10-14 days, as well as the use of O(2) for patients with hypoxia and non invasive or invasive ventilation in the case of acidosis and hypercapnia.

Acute exacerbations of chronic obstructive pulmonary disease (COPD) occur more frequently with increasing COPD severity and are associated with increased morbidity, reduced quality of life, and increased risk of mortality. The prevention and assessment of exacerbations, as a clinically and therapeutically relevant parameter, is a central aspect of clinical COPD studies. The aim of this review is to identify pitfalls in the analysis of the parameter of exacerbation and to describe the criteria that need to be considered in the statistical analysis of exacerbation studies.

Background: The clinical effects of mucolytics in patients with chronic obstructive pulmonary disease (COPD) are discussed controversially. Cineole is the main constituent of eucalyptus oil and mainly used in inflammatory airway diseases as a mucolytic agent. We hypothesised that its known mucolytic, bronchodilating and anti-inflammatory effects as concomitant therapy would reduce the exacerbation rate and show benefits on pulmonary function tests as well as quality of life in patients with COPD., Methods: In this double-blind, placebo-controlled multi-center-study we randomly assigned 242 patients with stable COPD to receive 200 mg of cineole or placebo 3 times daily as concomitant therapy for 6 months during winter-time. The frequency, duration and severity of exacerbations were combined as primary outcome measures for testing as multiple criteria. Secondary outcome measures included changes of lung function, respiratory symptoms and quality of life as well as the single parameters of the exacerbations., Results: Baseline demographics, lung function and standard medication of both groups were comparable. During the treatment period of 6 months the multiple criteria frequency, severity and duration of exacerbations were significantly lower in the group treated with cineole in comparison to placebo. Secondary outcome measures validated these findings. Improvement of lung function, dyspnea and quality of life as multiple criteria were statistically significant relative to placebo. Adverse events were comparable in both groups., Conclusion: Concomitant therapy with cineole reduces exacerbations as well as dyspnea and improves lung function and health status. This study further suggests cineole as an active controller of airway inflammation in COPD by intervening in the pathophysiology of airway inflammation of the mucus membrane., Trial Registration: ISRCTN07600011.

Background: As many as 50% of older smokers develop chronic obstructive pulmonary disease (COPD), and more than 80% of COPD-associated morbidity is caused by tobacco smoking. Despite the severe symptoms from which COPD patients suffer, they are often unable to quit smoking on their own., Methods: Experts from 9 medical societies, under the aegis of the German Society of Pulmonology and Respiratory Medicine (Deutsche Gesellschaft für Pneumologie und Beatmungsmedizin), have developed an S3 guideline on smoking cessation in COPD. They took previously published guidelines into account, as well as more than 2000 initially surveyed publications, and created the new guideline in two consensus conferences followed by a Delphi process., Results: The following strongly evidence-based statements can be made: A smoking cessation strategy based on a combination of medication and psychosocial support has been found to be effective in COPD patients. Smoking cessation improves pulmonary function, alleviates dyspnea and cough, reduces the frequency of COPD exacerbations, and lowers mortality. Mere smoking reduction does not improve pulmonary function or alleviate symptoms. Smoking cessation is the most effective and least expensive single means of lowering the risk of developing COPD and of arresting its progression. Smoking cessation should therefore be strongly promoted at all levels of health care delivery., Conclusions: There is no question that smoking cessation ranks among the most effective medical interventions, yet the German health care system still does not assign it an adequate priority.

Background: A standard outcome parameter for pharmacological trials in COPD has not yet been defined. Therefore, it is the aim of this review to evaluate frequently used parameters for their eligibility as assessment and outcome parameters in COPD., Methods: A review of the actual scientific literature was performed., Results: It is recommended to continue to rely primarily on the FEV (1), which has been used as a primary variable in the vast majority of trials. In addition, further parameters, such as FVC and IC/TLC should be determined. If available, additional information is provided by RV/TLC, K (co), PaO (2) and PaCO (2). FEV (1) is not a surrogate parameter for dyspnoea, quality of life, and exercise tolerance, which should therefore be assessed separately. Frequency and severity of exacerbations and mortality are important outcome parameters in long-term trials. Complex indices, such as the BODE index, may be superior to single variables., Conclusions: No single additional parameter has been evaluated sufficiently in order to substitute FEV (1) as the standard parameter for the assessment and outcome in COPD.

The concept of the minimal clinically important difference (MCID) is intended to provide a measure of relevance for a statistically applied in patients with COPD. Clinically important differences are those differences relevant to the individual patient and important to the patient's life. However, people's difference in a diagnostic parameter perception of what is important vary. Furthermore, physicians may rate the significance of a particular marker and its difference which can be achieved by a pharmacological intervention differently from the patient. Thus, the major problem with defining an MCID for any measure is that the most important differences, which require the most subtle measures for an individual patient, are likely to have the least general application. Conversely, measures that can be generalised are unlikely to have much individual importance and will be very crude tools for an individual assessment. In medical trials both, statistical rigor and clinical relevance are generally required, and MCID is without doubt a key application tool defining treatment success or treatment failure. This paper gives an update on the concept of a minimal important difference of most relevant parameters in COPD treatment.

Asthma and COPD are common diseases inducing high costs. In national and international guidelines exercise training is stated as the main component amongst the nonmedical treatment options. With exercise training beneficial effects in exercise performance, quality of life and health-related costs can be obtained. Options for exercise training all over the country should be established. Therefore not only inpatient, but also outpatient structures, especially lung sports groups have to be organized to enable a continuous training. For this special way of long term training no systematic guidelines do exist. Further aggravating factors are the different basic vocational education of the trainers and the heterogeneity of the participants. The intention of the authors was to develop recommendations for a structured training and training sensitive to the target group. The realisation of training with this approach should approximate training to evidence based knowledge and contribute to the quality of training patients with lung diseases.

Background: The partition and chronological sequence of the different training items and modalities necessary for an effective training of patients with chronic obstructive pulmonary disease (COPD) remains a subject of debate. We investigated the combination of effective components of pulmonary rehabilitation in the settings outpatient lung sports group, home-based training and training in a gym., Methods: Subjects were randomized to a 12-month training program and a no training group., Patients and Main Results: The training group (n = 10, mean age: 62.5 years, FEV1 53.4% predicted) reached an average increase in peakVO2 of 10% (p = 0.01) from 1.30 +/- 0.41 L/minute to 1.44 +/- 0.38 L/minute, in peak work rate of 14% (p = 0.007) from 82 +/- 39 W to 93 +/- 43 W and in the six-minute walking distance of 79 meters (p = 0.003), whereas in the control group (n = 9, mean age: 63.2 years, FEV1 53.7% predicted) no significant changes were observed. The quality of life obtained by use of the SF36-questionnaire and SGRQ also significantly improved in the training group, but not in the control group., Conclusion: This outpatient rehabilitation program is effective and appropriate for long-term rehabilitation of patients with COPD.