An Open-label, Randomised, Cross-over, Single Centre Study in Healthy Volunteers to Optimise the Rotacap Formulation andROTAHALER Device for Delivery of Fluticasone Propionate/Salmeterol.

BACKGROUND:

Asthma is a chronic inflammatory disease of the airways characterised by varying and recurring symptoms of shortness of breath, chest tightness, wheezing and cough, airflow obstruction, bronchial hyper-responsiveness and underlying inflammation.

The GINA guidelines [Global Initiative for Asthma,(GINA) updated 2009] highlight the need to treat airway inflammation in asthma and recognise the importance of inhaled prophylactic medications such as inhaled corticosteroids and combinations of Inhaled Corticosteroids (ICS) / Long Acting Beta Agonists (LABA) such as SERETIDE™ for the treatment of chronic asthma.

Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterised by airflow limitation that is not fully reversible [Celli, 2004]. The airflow limitation of COPD is primarily due to small airways disease and parenchymal destruction associated with an abnormal inflammatory response of the lungs, mainly caused by cigarette smoking [Celli 2004]. COPD is characterised by symptoms of chronic and progressive breathlessness (or dyspnea), cough and sputum production which can be a major cause of disability and anxiety associated with the disease.

The GOLD (Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease) guidelines on COPD state that the goals of pharmacologic therapy should be to control symptoms, improve health status and exercise tolerance, and reduce the frequency of COPD exacerbations [GOLD, 2008]. Research has indicated that an inhaled corticosteroid (ICS) combined with a long acting β2-agonist (LABA) is more effective than the individual components in managing stable COPD to reduce exacerbations and improve lung function and health status [Ferguson, 2008; Calverley, 2007; Kardos, 2007].