Extrait

Background and study aims Clinical studies provide useful information regarding both the safety and effectiveness of medicines, but clinical trial settings are not always as close to a real-world setting as they could be, often due to the excluding of patients taking specific medications or with other specific conditions, and the patients are also often intensively monitored throughout the study. Indacaterol is a drug used for the treatment of chronic obstructive pulmonary disease (COPD). It is taken once a day to open up the airways that will have become narrowed as part of the disease process of COPD. The aim of this study is to measure the impact of indacaterol on individual patients in a real-world setting, where the patients have been prescribed indacaterol as their standard therapy following a clinical assessment for their COPD. Who can participate? The study is open to patients in selected GP practices in the UK that have chosen to participate. Patients must be aged over 18 and have been prescribed indacaterol for COPD. What does the study involve? This study uses data from routine clinical examinations. In addition to standard measurements, patients will also be requested to complete two straightforward questionnaires at specified timepoints during the study andwill also be requested to rate their overall opinion of the effectiveness of indacaterol at the end of the study. Patients in the study will be monitored for a total of 6 months, with a visit between 6 and 8 weeks after the start of the study. What are the possible benefits and risks of participating? There may be a potential benefit for participating patients in terms of improved monitoring of their COPD, though this study has been designed to be close to the standard monitoring of COPD patients starting a new medication. The only potential impact for patients is the short amount of time required to complete the two short questionnaires. Where is the study run from? Novartis Pharmaceuticals UK Ltd. When is the study starting and how long is it expected to run for? From April 2012 to August 2013. Who is funding the study? Novartis Pharmaceuticals UK Ltd. Who is the main contact? Dr Amr Radwan

Critère d'inclusion

• Chronic Obstructive Pulmonary Disease (COPD)

Liens

• isrctn
• ictrp