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George E Taffet,1 James F Donohue,2 Pablo R Altman31Geriatrics Section, Geriatrics and Cardiovascular Sciences, Baylor College of Medicine, The Methodist Hospital, Houston, TX, 2Pulmonary Diseases and Critical Care Medicine, University of North Carolina, Chapel Hill, NC, 3Medical Affairs, Mylan Specialty L.P., Basking Ridge, NJ, USAAbstract: Chronic obstructive pulmonary disease (COPD) is common in older people, with an estimated prevalence of 10% in the US population aged ≥75 years. Inhaled medications are the cornerstone of treatment for COPD and are typically administered by one of three types of devices, ie, pressurized metered dose inhalers, dry powder inhalers, and nebulizers. However, age-related pulmonary changes may negatively influence the delivery of inhaled medications to the small airways. In addition, physical and cognitive impairment, which are common in elderly patients with COPD, pose special challenges to the use of handheld inhalers in the elderly. Health care providers must take time to train patients to use handheld inhalers and must also check that patients are using them correctly on a regular basis. Nebulizers should be considered for patients unable to use handheld inhalers properly. What follows is a review of issues associated with COPD and its treatment in the elderly patient.Keywords: chronic obstructive pulmonary disease, inhaler, device, cognition, disability, comorbidities, maintenance therapy

James F Donohue1, Paul W Jones21Division of Pulmonary Disease and Critical Care Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; 2St. George's, University of London, London, UKAbstract: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Developments in the understanding of COPD have led to standard guidelines for diagnosis, treatment, and spirometry assessments, which have in turn influenced trial designs and inclusion criteria. Substantial clinical evidence has been gained from clinical trials and supports a positive approach to COPD management. However, there appear to be changing trends in recent trials. Large bronchodilator studies have reported lower improvements in trough forced expiratory volume in 1 second (FEV1) values versus placebo than were observed in earlier studies, while the rate of FEV1 decline seems to be lower in more recent trials. In addition, recent evidence has called into question the usefulness of bronchodilator reversibility testing as a trial inclusion criterion. Baseline patient populations and use of concomitant medications have also changed over recent years due to increased treatment options. The impact of these many variables on clinical trial results is explored, with a particular focus on changes in inclusion criteria and patient baseline demographics.Keywords: chronic obstructive pulmonary disease, clinical trials, forced expiratory volume in 1 second, long-acting bronchodilators, lung function

James F Donohue1, Dave Singh2, Oliver Kornmann3, David Lawrence4, Cheryl Lassen4, Benjamin Kramer5 1University of North Carolina, Chapel Hill, NC, USA; 2University of Manchester, Medicines Evaluation Unit, Manchester, UK; 3IKF Pneumologie GmbH and Co KG, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany; 4Novartis Horsham Research Centre, Horsham, UK; 5Novartis Pharmaceuticals Inc, East Hanover, New Jersey, USA Purpose: Pooled data were analyzed to evaluate the safety and tolerability of indacaterol, a once-daily inhaled long-acting ß2-agonist for chronic obstructive pulmonary disease (COPD). Patients and methods: Data were pooled from clinical studies of 3–12 months’ duration in patients with moderate-to-severe COPD receiving double-blind indacaterol 75 µg (n = 449), 150 µg (n = 2611), 300 µg (n = 1157), or 600 µg once daily (n = 547); formoterol 12 µg twice daily (n = 556); salmeterol 50 µg twice daily (n = 895); placebo (n = 2012); or tiotropium 18 µg once daily, given open label or blinded (n = 1214). Outcomes were adverse events, serious adverse events and deaths, plasma potassium, blood glucose, and QTc interval and vital signs. Results: The commonest adverse events with indacaterol were COPD worsening, nasopharyngitis, and headache; most cases were mild or moderate and incidence was generally similar to placebo and other active treatments. The risk of acute respiratory serious adverse events (leading to hospitalization, intubation, or death) was not significantly increased with any of the active treatments compared with placebo. COPD exacerbation rates (analyzed in the intent-to-treat population) were significantly reduced with all active treatments versus placebo. Hazard ratios versus placebo for major cardiovascular adverse events were <1 for all indacaterol doses. Notable values for vital signs and measures of systemic ß2-adr

Nicholas J Gross1, James F Donohue21Hines VA Hospital, Stritch Loyola School of Medicine, Hines, IL, USA; 2University of North Carolina School of Medicine, Chapel Hill, NC, USAAbstract: A nebulized formulation of formoterol, Perforomist®, 20 μg/2 ml, has been available since 2007 for the maintenance treatment of chronic obstructive pulmonary disease (COPD). We review the safety and efficacy data obtained during its development. In a dose-finding study, formoterol inhalation solution (FFIS) was similar to the formoterol originator, Foradil® 12 μg DPI (FA) in patients with COPD. In a 12-week efficacy study, FFIS manifested a rapid onset of action and FEV1 peak, AUC0–12, and trough levels similar to FA. No loss of efficacy, tachyphylaxis, was observed over 12 weeks of regular administration. In placebo-controlled studies in COPD patients receiving maintenance tiotropium, the addition of FFIS significantly augmented bronchodilation over the 6-week treatment duration, signifying that nebulized formoterol can further improve lung function in patients who are receiving tiotropium without an observed increase in adverse reactions. The safety profile of FFIS during 12-week and 1-year studies revealed adverse events that were similar to those of placebo and FA. Cardiac rhythm studies, including frequent ECGs and Holter monitoring, did not indicate any increase in rate or rhythm disturbances greater than placebo or FA. We conclude that maintenance use of Perforomist® is appropriate for patients with COPD who require or prefer a nebulizer for management of their disease.Keywords: long-acting bronchodilator, β-agonist, chronic bronchitis, pulmonary emphysema, Perforomist®, chronic obstructive pulmonary disease

Barbara P Yawn1, Douglas W Mapel2, David M Mannino3, Fernando J Martinez4, James F Donohue5, Nicola A Hanania6, Mark Kosinski7, Regina Rendas-Baum7, Matthew Mintz8, Steven Samuels9, Anand A Dalal10, On behalf of the Lung Function Questionnaire Working Group*1Olmsted Medical Center, Department of Research, Rochester, MN, USA; 2Lovelace Clinic Foundation, Albuquerque, NM, USA; 3University of Kentucky School of Medicine, Lexington, KT, USA; 4University of Michigan Health System, Ann Arbor, MI, USA; 5University of North Carolina School of Medicine, Chapel Hill, NC, USA; 6Baylor College of Medicine, Houston, TX, USA; 7QualityMetric, Inc., Lincoln, RI, USA; 8George Washington University School of Medicine, Washington, DC, USA; 9Indiana Internal Medicine Consultants, Greenwood, IN, USA; 10GlaxosmithKline, Research Triangle Park, NC, USA; *The Lung Function Questionnaire Working Group includes Barbara P Yawn, Douglas W Mapel, David M Mannino, Fernando Martinez, James Donohue, Nicola Hanania, Matthew Mintz, and Steven SamuelsObjective: To describe the item-selection and item-reduction for the Lung Function Questionnaire (LFQ), being developed to help clinicians identify patients appropriate for diagnostic evaluation for chronic obstructive pulmonary disease (COPD) using spirometry.Methods: Item selection and reduction were based on information from 387 ≥40-year-old respondents to the third National Health and Nutrition Examination Survey who had self-reported chronic bronchitis. Item reduction involved stepwise logistic regression. The accuracy of the final subset of items for identifying individuals with airflow obstruction (forced expiratory volume in one second/forced vital capacity <0.70) versus those without it was assessed with receiver operating characteristic analysis. Content and face validity were assessed using focus groups of primary care physicians (n = 16) and interviews with COPD patients (n = 16).Results: The model with all five items (age; smok

Where, when and how (indeed whether) academic writing should be taught to university students, who are not necessarily aiming to study ‹language› per se, has long been a concern in higher education. While students need to develop high level communication skills, in genres often quite specific to higher education, in order that their learning can be assessed, teaching them academic writing during the course of their disciplinary studies raises a number of pedagogical, organisational and research issues. This paper reports on a collaboration between a group of academics in different geographic and institutional locations, who share a dream of improving student learning through curriculum-integrated teaching of writing. Their project has attempted to apply a model of ‹learning development› practice that works well in one arena to a range of new contexts, in order to test its efficacy and transferability. Results indicate that the pedagogical strategies tried (e. g. collaborative, inter-disciplinary design of learning tasks, resources and assessment processes based on analysis of contextually-specific literacy demands) prove ‹true› in various situations, enabling positive changes – in student learning, in the design of curricula, in teachers’ professional development and in general perceptions of the role of language in learning.