SITUATION Chronic obstructive pulmonary disease (COPD) is a progressive disease that makes breathing difficult and is a leading cause of mortality worldwide. Although up to half of all COPD exacerbations are not reported by patients, exacerbations worsen COPD symptoms and lung function, lead to hospitalization or death and negatively impact a patient’s quality of life. A leading global pharmaceutical sponsor began a program of clinical trials to discover if a new bronchodilator could demonstrate superior and sustained lung function for the long-term maintenance of airflow obstruction of patients with COPD, including chronic bronchitis and emphysema. ERT provided integrated Respiratory, eCOA, Cardiac Safety and Enhanced Business Intelligence for Respiratory Trials solutions for

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