CAT score single item analysis in patients with COPD: results from COSYCONET

Abstract The COPD Assessment Test (CAT) is in widespread use for the evaluation of patients with chronic obstructive pulmonary disease (COPD). We assessed whether the CAT items carry additional information beyond the sum score regarding COPD characteristics including emphysema. Patients of GOLD grades 1 to 4 from the COPD cohort COSYCONET (German COPD and Systemic Consequences - Comorbidities Network) with complete CAT data were included (n = 2270), of whom 493 had chest CT evaluated for the presence of emphysema. Comorbidities and lung function were assessed following standardised procedures. Cross-sectional data analysis was based on multiple regression analysis of the single CAT items ag…

Triple therapy de-escalation to dual bronchodilation in COPD patients: Baseline data from the DACCORD cohort

Background: GOLD recommends triple therapy only in COPD patients with frequent exacerbations despite long-acting bronchodilators who exhibit a high blood eosinophil level (≥300/μL). Indication for ICS containing therapy should be reassessed regularly. Methods: The German real life study DACCORD included COPD patients who had received free triple therapy for ≥ 6 months prior to study entry. At baseline, patients were switched to LABA+LAMA fixed-dose combination (FDC) or maintained triple therapy upon discretion of the treating physician. Here, we compare baseline data of the 2 groups. Results: 1182 patients were recruited into DACCORD of which 30.7% were moved to LABA+LAMA FDC. Patients in t…

GOLD 2017 treatment pathways in ‘real life’: An analysis of the DACCORD observational study

Abstract 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 β2-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/L…

Treatment Initiation in Therapy-Naive COPD Patients: An Analysis of the German Real-Life Daccord Register

Inhaled steroids and prevalence of osteoporosis in chronic obstructive pulmonary disease: Data from the DACCORD cohort

Introduction: Osteoporosis is a frequent COPD comorbidity with age, female gender, smoking, immobility and the use of oral steroids (OCS) as common risk factors. The role of inhaled steroids (ICS) is still under debate. Methods: Baseline data from the real life cohort DACCORD were analyzed. The diagnosis of osteoporosis was based on patients’ reports of physician-based diagnoses. Associations of ICS exposure at time of inclusion and osteoporosis were examined by group comparisons and multivariable logistic regression analyses with age, gender, smoking, exacerbation history (EH) and FEV1% as covariates. To avoid interactions with other steroid containing medications, exposure to any corticos…

Dual bronchodilation vs triple therapy in the “real-life” COPD DACCORD study

Roland Buhl,1 Carl-Peter Criée,2 Peter Kardos,3 Claus F Vogelmeier,4 Konstantinos Kostikas,5 Nadine S Lossi,6 Heinrich Worth7 1Pulmonary Department, Mainz University Hospital, Mainz, 2Department of Sleep and Respiratory Medicine, Evangelical Hospital Goettingen-Weende, Bovenden, 3Group Practice and Centre for Allergy, Respiratory and Sleep Medicine, Red Cross Maingau Hospital, Frankfurt am Main, 4Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany; 5WorldWide Medical Affairs Respiratory, Novartis Pharma AG, Basel, Switzerland;…

The German COPD cohort COSYCONET: Aims, methods and descriptive analysis of the study population at baseline

Abstract Background The German COPD cohort study COSYCONET (" CO PD and SY stemic consequences- CO morbidities NET work") investigates the interaction of lung disease, comorbidities and systemic inflammation. Recruitment took place from 2010 to 2013 in 31 study centers. In addition to the baseline visit, follow-up visits are scheduled at 6, 18, 36 and 54 months after baseline. The study also comprises a biobank, image bank, and includes health economic data. Here we describe the study design of COSYCONET and present baseline data of our COPD cohort. Methods Inclusion criteria were broad in order to cover a wide range of patterns of the disease. In each visit, patients undergo a large panel …

Change of COPD maintenance medication over two years in a large real life cohort: The DACCORD study

Introduction Database studies suggest a steady intensification of COPD maintenance medication, with the majority of patients eventually receiving a LABA/LAMA/ICS combination. However, such studies include generally only data on medication use. Here, we analysed data from the ongoing, non-interventional, observational DACCORD study to determine whether there was a correlation between baseline GOLD 2011 category and change in medication use over 2 years. Methods This abstract presents data on medication use at baseline and at 1 and 2 years, by baseline GOLD 2011 category (A,B,C and D with symptoms evaluated using the COPD Assessment Test). Results 3315 patients with COPD have completed the 2 …

Disease Progression in COPD Patients Classified as Gold D According to Gold 2011 or Gold 2017 in the Real-Life Daccord Study

P120 Real life distribution of COPD severity in the German DACCORD registry: Lung function is the main driver of classification in GOLD group C and D

Introduction Currently there is limited real-life data available regarding the distribution of COPD patients using the GOLD 2011 criteria. The German DACCORD registry that collects data from a large ‘real life’ population sample was used to categorise COPD patients according to GOLD 2011. Methods To be eligible for entry into DACCORD, all patients had to have a diagnosis of COPD (consistent with the German Disease Management Programme definition), and, prior to entry, had to have either newly initiated bronchodilator maintenance medication, or to have a bronchodilator added to their maintenance regimen. No other inclusion criteria were applied, and the only exclusion criterion was a diagnos…

Initiation of Mono vs. Dual Bronchodilation in the Therapy-Naive COPD Patient in the German Daccord Cohort

WITHDRAWN: Scaling up strategies of the Chronic Respiratory Disease programme of the European Innovation Partnership on Active and Healthy Ageing (Action Plan B3 – Area 5)

Guideline-based survey of outpatient COPD management by pulmonary specialists in Germany

Thomas Glaab1,2, Claus Vogelmeier3, Andreas Hellmann4, Roland Buhl11Department of Respiratory Diseases III, Medical Center of the Johannes Gutenberg-University, Mainz, 2Medical Affairs Germany, Respiratory Medicine, Boehringer Ingelheim Pharma GmbH and Co, KG, Ingelheim, 3Department of Respiratory Diseases, University Hospitals of Giessen and Marburg, Marburg, 4Federal Association of Pneumologists, Augsburg, GermanyBackground: Little is known about the role of guidelines for the practical management of chronic obstructive pulmonary disease (COPD) by office-based pulmonary specialists. The aim of this study was to assess their outpatient management in relation to current guideline recommenda…

The ‘real-life’ COPD patient in Germany: The DACCORD study

Abstract 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 (FEV 1 ). Results Approximately…

S2k-Leitlinie zur Diagnostik und Therapie von Patienten mit Asthma

ZusammenfassungDie vorliegende Leitlinie ist eine Neufassung und Aktualisierung der Leitlinie zur Diagnostik und Therapie von Patienten mit Asthma, welche die bisher für den deutschen Sprachraum gültige Version aus dem Jahr 2006 ablöst. Die Fülle an neuen Erkenntnissen zur Pathophysiologie und zu den Phänotypen von Asthma und das erweiterte Spektrum an diagnostischen und therapeutischen Möglichkeiten bei dieser Erkrankung machte eine Neufassung und Aktualisierung notwendig. Es werden sowohl für Kinder und Jugendliche als auch für Erwachsene mit Asthma die aktuellen, Evidenz-basierten diagnostischen und therapeutischen Empfehlungen dargelegt.

The Effect of Tiotropium/Olodaterol versus Salmeterol/Fluticasone on Left Ventricular Function and Lung Hyperinflation in Patients with COPD

Patients in clinical trials on COPD triple therapy compared to real world populations

Allergen-Immuntherapie in der aktuellen COVID-19-Pandemie – ein Positionspapier von ARIA, EAACI, AeDA, GPA und DGAKI (Kurzversion) – Positionspapier der deutschen ARIA-GruppeA in Kooperation mit der österreichischen ARIA-GruppeB, der schweizerischen ARIA-GruppeC, dem Ärzteverband Deutscher Allergologen (AeDA)D, der Deutschen Gesellschaft für Allergologie und Klinische Immunologie (DGAKI)E und der Gesellschaft für Pädiatrische Allergologie (GPA)F in Kooperation mit der AG Klinische Immunologie, Allergologie und Umweltmedizin der DGHNO-KHCG und der Europäischen Akademie für Allergologie und Klinische Immunologie (EAACI)H

A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT® Study Protocol

Roland Buhl,1 Michael Dreher,2 Stephanie Korn,1 Christian Taube,3 Christian Stock,4 Christoph M Zehendner,5 Anke Kondla,5 Claus F Vogelmeier6 1Pulmonary Department, Johannes Gutenberg University Mainz, Mainz, Germany; 2Clinic of Cardiology, Pneumology, Angiology and Internal Medicine Intensive Care, University Hospital RWTH Aachen, Aachen, Germany; 3Clinic for Pneumonology, University Medicine Essen – Ruhrlandklinik, Essen, Germany; 4Biostatistics + Data Sciences Corp, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 5HP Country Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; 6Department of Pneumology,…

Relationship between clinical and radiological signs of bronchiectasis in COPD patients: Results from COSYCONET.

Bronchiectasis (BE) might be frequently present in COPD but masked by COPD symptoms. We studied the relationship of clinical signs of bronchiectasis to the presence and extent of its radiological signs in patients of different COPD severity. Visit 4 data (GOLD grades 1-4) of the COSYCONET cohort was used. Chest CT scans were evaluated for bronchiectasis in 6 lobes using a 3-point scale (0: absence, 1: ≤50%, 2: >50% BE-involvement for each lobe). 1176 patients were included (61%male, age 67.3y), among them 38 (3.2%) with reported physicians' diagnosis of bronchiectasis and 76 (6.5%) with alpha1-antitrypsin deficiency (AA1D). CT scans were obtained in 429 patients. Within this group, any sign…

Seasonal Distribution Of Exacerbations In The Poet-COPD; Study

Evidenz für eine frühzeitige Therapie der COPD mit Tiotropium

Hintergrund: Die Wirksamkeit von Tiotropium versus Kontrolle wurde in einer praspezifizierten Subgruppenanalyse der 4-Jahres-Studie „Understanding Potential Long-term Impacts on Function with Tiotropium“ bei Patienten mit chronisch obstruktiver Lungenerkrankung (COPD) mittleren Schweregrades (GOLD II) untersucht und erstmals den gepoolten Ergebnissen aus den schwereren Krankheitsstadien (GOLD III/IV) gegenubergestellt. Methode: Randomisierte multizentrische, doppelblinde, kontrollierte Studie mit parallelem Gruppenvergleich bei 5993 Patienten uber 4 Jahre. Die Patienten erhielten entweder Tiotropium 18 µg einmal taglich oder Plazebo. Als Endpunkte wurden der jahrliche FEV1-Abfall und weiter…

Tiotropium Reduces Exacerbations Versus Salmeterol Irrespective Of Baseline ICS Treatment In The Poet-COPD; Study

S2k-Leitlinie zur Diagnostik und Therapie von Patienten mit Asthma – Addendum 2020

ZusammenfassungDas vorliegende Addendum zur Leitlinie zur Diagnostik und Therapie von Patienten mit Asthma (2017) ergänzt wichtige neue Erkenntnisse zur Diagnostik und Therapie von Asthma sowie zu neu für die Therapie des Asthmas zugelassenen Medikamenten. Es werden sowohl für Kinder und Jugendliche als auch für Erwachsene mit Asthma die aktuellen, Evidenz-basierten diagnostischen und therapeutischen Empfehlungen dargelegt.

Leitlinie zur Diagnostik und Therapie von Patienten mit chronisch obstruktiver Bronchitis und Lungenemphysem (COPD)

ZusammenfassungDas vorliegende Dokument ist eine Neufassung und Aktualisierung der Leitlinie zur Diagnostik und Therapie von Patienten mit COPD, die die bisherige Version aus dem Jahr 2007 ablöst. Die Fülle an neuen Erkenntnissen zu Risikofaktoren, Diagnostik, Schweregradeinschätzung, Prävention und medikamentösen sowie nicht medikamentösen Therapiemaßnahmen machten eine umfassende Überarbeitung erforderlich. Die neue Leitlinie baut auf das GOLD-Dokument unter Berücksichtigung von Besonderheiten in Deutschland und Österreich auf.

Characterization of COPD Patients Experiencing Clinically Relevant Improvement Vs Worsening in Health Status 2 Years After a Change of Maintenance Treatment in the 'Real-life' Daccord Study

P141 2-year follow-up of COPD patients in the non-interventional ‘real-life’ daccord study in germany

Introduction Although randomised, controlled trials are important in the development of new pharmacological treatments, they provide limited information on the ‘real life’ management of chronic diseases. Here, we analysed two-year follow-up data from the prospective, non-interventional, observational DACCORD study to evaluate the frequency of exacerbations and the evolution of disease severity using GOLD 2011 categorization. Methods COPD out-patients were recruited into DACCORD following either a change or initiation of COPD maintenance medication and followed up for 2 years. Data of 3137 patients that completed the 2-year follow-up were analysed; Exacerbation data were collected from the 6…

The effect of tiotropium/olodaterol versus fluticasone propionate/salmeterol on left ventricular filling and lung hyperinflation in patients with COPD

This exploratory, randomised, double-blind, double-dummy, multicentre, cross-over study explored the effect of 6 weeks of treatment with tiotropium/olodaterol (T/O) versus fluticasone propionate/salmeterol (F/S) on left ventricular filling in patients with chronic obstructive pulmonary disease with functional residual capacity (FRC) >120% predicted and postbronchodilator improvement of FRC ≥7.5%. Overall, 76 patients were randomised across nine sites. Treatment with T/O or F/S increased left ventricular end-diastolic volume index from baseline (adjusted mean change: T/O: 2.317 mL/m2, F/S: 2.855 mL/m2), with no statistically significant difference between treatments. However, T/O resulted…

P285 The ‘real-life’ copd patient in the age of laba/lamas: an expansion of the daccord study

Introduction The prospective, non-interventional DACCORD study collects data from a representative cohort of COPD out-patients across Germany who either initiated or changed COPD maintenance medication prior to entry. Initially, DACCORD consisted of two treatment groups (Glycopyrronium-based therapy vs. any other COPD maintenance medication with the exception of Glycopyrronium). Following the approval of LABA/LAMA fixed-dose combinations (FDC) in 2013, DACCORD was extended to follow an additional cohort of patients receiving any LABA/LAMA FDC over a period of 2 years. Methods 5223 patients with complete baseline data (3815 LAMA/LABA FDC vs. 1408 standard treatment group) were analysed here.…

2 years in the life of COPD patients: Evolution of GOLD 2011 classification in the 'real-life' DACCORD study

Introduction Limited data are available on the progression of COPD categorised according to GOLD 2011. We analysed data from the ongoing, non-interventional, observational DACCORD study and compared baseline GOLD 2011 categorisation with that of 1 and 2-years after inclusion. Methods Patients with a diagnosis of COPD were recruited into DACCORD following either a change or initiation of maintenance medication. Baseline exacerbations data (collected over 6 months) were annualised for GOLD categorisation at baseline; COPD symptoms were evaluated using the COPD Assessment Test (CAT) at baseline as well as the 1 year and 2 year visit. Data on exacerbations were collected every 3 months up to 2 …

P46 Frequency of COPD exacerbations in the German DACCORD Registry

Introduction In patients with COPD, exacerbations are among the most relevant safety measures. In this analysis of data from the observational DACCORD study, we report the frequency of exacerbations in a COPD population. Methods To get insights into occurrence and frequency of exacerbations, data from 4,123 patients were obtained from 349 primary and secondary care centres in Germany. To be eligible for entry into DACCORD, all patients had to have a COPD diagnosis (consistent with the German Disease Management Programme definition), and had to have a change in bronchodilator maintenance medication, prior to entry. Data collected included history and treatment of exacerbations 6 months prior…

“Real-life” inhaled corticosteroid withdrawal in COPD: a subgroup analysis of DACCORD

Claus Vogelmeier,1 Heinrich Worth,2 Roland Buhl,3 Carl-Peter Criée,4 Nadine S Lossi,5 Claudia Mailänder,5 Peter Kardos6 1Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Member of the German Center for Lung Research (DZL), Marburg, 2Facharzt Forum Fürth, Fürth, 3Pulmonary Department, Mainz University Hospital, Mainz, 4Department of Sleep and Respiratory Medicine, Evangelical Hospital Göttingen-Weende, Bovenden, 5Clinical Research, Respiratory, Novartis Pharma GmbH, Nürnberg, 6Group Practice and Centre for Allergy, Respiratory and Sleep Medicine, Re…

COPD in elderly patients – an analysis of the DACCORD observational study

Introduction: In elderly patients COPD is frequently complicated by the presence of several comorbidities and the many non-COPD-related medications prescribed to treat these conditions. This analysis aims to characterize COPD patients above the age of 75 in a real-world cohort in Germany. Methods: DACCORD is a prospective, non-interventional study collecting data from COPD patients treated in primary and secondary care. Prior to study entry, patients either initiated or changed COPD maintenance medication. Moderate/severe exacerbations, COPD-medication and non-COPD medication were documented at baseline and every 3 months. Comorbidities were documented at baseline. Results: Baseline charact…

Baseline Characteristics According To Gender In A Large Exacerbations Trial

Long-term general and cardiovascular safety of tiotropium/olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease

Abstract Background Long-term safety, particularly cardiovascular safety, is of special interest in maintenance treatment of chronic obstructive pulmonary disease (COPD) with long-acting β 2 -agonists and long-acting muscarinic antagonists, given potential cardiovascular effects. Methods Two 52-week Phase III trials (TONADO ® ) investigated tiotropium/olodaterol (5/5 and 2.5/5 μg) versus tiotropium 2.5, 5 μg and olodaterol 5 μg. In a pre-specified safety analysis, investigator-reported treatment-emergent adverse events (AEs), electrocardiogram and laboratory data were pooled. All serious AE (SAE) reports were reviewed by an independent Adjudication Committee, which assessed whether deaths, …

Anti-interleukin-5 therapy (mepolizumab) in life-threatening asthma attack: A case-based discussion

We report about a case of a compassionate off-label use of the anti-interleukin-5-agent mepolizumab in a ventilated patient with life-threatening asthma attack in eosinophilic asthma. The patient suffered from severe eosinophilic asthma and was transmitted to our hospital with an asthma attack and a life-threatening respiratory state under ventilation. Since high dose steroids had not yielded a sufficient respiratory improvement mepolizumab was administered subcutaneously. After administration of mepolizumab respiratory state and ventilation parameter improved significantly. Two days after administration the patient was weaned could be extubated 8 days later and recovered completely from th…

Switch from LABA+ICS to a LABA/LAMA combination in symptomatic women with COPD – an analysis of the observational DACCORD study

Introduction: COPD prevalence in women has increased in recent years and the importance of avoiding ICS use in this group, because of its potential negative impact on comorbidities such as osteoporosis and diabetes, has become a topic of interest. In this real-life cohort women with COPD that were switched from LABA+ICS treatment to a fixed combination of LABA/LAMA were followed for 1 year. Methods: DACCORD is a prospective, non-interventional 2-year study in the primary and secondary care setting throughout Germany. Patients were recruited after a change in, or initiation of COPD maintenance medication. Data collected at baseline and every 3 months included moderate/severe exacerbations an…

A two-year evaluation of the ‘real life’ impact of COPD on patients in Germany: The DACCORD observational study

Abstract 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 volu…

The frequent exacerbator in real-life: an analysis of the DACCORD study

Introduction: Exacerbation prevention is a major treatment goal in COPD. Hence, exacerbations are a decisive diagnostic and prognostic factor when it comes to therapy. The non-interventional prospective DACCORD study was following COPD patients for 2 years. Here, we compare patients with frequent exacerbations, non-frequent exacerbations and no exacerbations in the 6 months prior to study entry. Methods: DACCORD recruited COPD patients following a change or initiation of COPD maintenance. Data collected at baseline and every 3 months include exacerbations and COPD medication use. COPD Assessment Test (CAT) data were collected anually. Results: Out of 6527 patients, 7.1% were frequent exacer…

A year in the life of German patients with COPD: the DACCORD observational study

Roland Buhl,1 Carl-Peter Criée,2 Peter Kardos,3 Claus Vogelmeier,4,5 Nadine Lossi,6 Claudia Mailänder,6 Heinrich Worth7 1Pulmonary Department, Mainz University Hospital, Mainz, 2Department of Sleep and Respiratory Medicine, Evangelical Hospital Göttingen-Weende, Bovenden, 3Group Practice and Centre for Allergy, Respiratory and Sleep Medicine, Red Cross Maingau Hospital, Frankfurt am Main, 4Department of Medicine, Pulmonary, and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, 5German Center for Lung Research, Marburg, 6Clinical Research Primary Care, Novartis Pharma GmbH, Nürnberg, 7Facharztforum F&…

Prevention Of COPD Exacerbations With Tiotropium Versus Salmeterol: Pooled Analysis From Clinical Studies

The effect of adjustable dosing with budesonide/formoterol on health-related quality of life and asthma control compared with fixed dosing

Budesonide/formoterol in a single inhaler is an effective therapy for asthma. We investigated whether adjustable maintenance dosing with budesonide/formoterol could maintain health-related quality of life (HRQL) and asthma control.Asthma patients (n = 4025) received budesonide/formoterol (Symbicort 160/4.5 microg) 2 inhalations twice daily (b.i.d.) for 4 weeks during run-in of this open, multicentre study. Patients were randomised to adjustable dosing (budesonide/formoterol 1 inhalation b.i.d.; stepping up to 2 or 4 inhalations bid for 1 week if asthma worsened) or fixed dosing (budesonide/formoterol 2 inhalations b.i.d.), for 12 weeks. Change in HRQL (standardised Asthma Quality of Life Qu…

Cabbage and fermented vegetables: from death rate heterogeneity in countries to candidates for mitigation strategies of severe COVID-19

International audience; Large differences in COVID-19 death rates exist between countries and between regions of the same country. Some very low death rate countries such as Eastern Asia, Central Europe, or the Balkans have a common feature of eating large quantities of fermented foods. Although biases exist when examining ecological studies, fermented vegetables or cabbage have been associated with low death rates in European countries. SARS-CoV-2 binds to its receptor, the angiotensin-converting enzyme 2 (ACE2). As a result of SARS-CoV-2 binding, ACE2 downregulation enhances the angiotensin II receptor type 1 (AT1 R) axis associated with oxidative stress. This leads to insulin resistance …

P128 Pooled safety analysis of adjudicated serious adverse events with the combination of tiotropium + olodaterol: Abstract P128 Table 1

Rationale This analysis aimed to obtain a comprehensive and objective safety assessment of the combination of tiotropium (T), a long-acting muscarinic antagonist, with olodaterol (O), a long-acting β2-agonist, (T+O) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Methods Data from two, 52-week, pivotal Phase III trials investigating T+O 5/5 µg and T+O 2.5/5 µg versus T 2.5 µg, 5 µg and O 5 µg were pooled, and patient narratives and profiles of serious adverse-event (SAE) reports were reviewed by an independent Adjudication Committee. The committee members independently assessed all SAEs to determine if any deaths, hospitalisations or intubations were r…