Table 1.

Study endpoints

Endpoint	Definitions
Primary endpoint
Mean annual rate of moderate or severe exacerbations	• Moderate exacerbation: patient receiving an exacerbation-related prescription of oral corticosteroids and/or antibiotic (with or without NHS contact) not requiring hospitalisation
	• Severe exacerbation: an exacerbation-related hospitalisation
Secondary endpoints
• COPD-related secondary care contacts	• Respiratory-related contacts: contact where the most prominent signs and symptoms with which the patient presents are as a direct result of the patient’s COPD
• COPD-related primary care contacts
	• All contacts: any interaction between the patient and a doctor or nurse working as part of the NHS (including telephone calls), not including protocol-defined study-related visits
• All secondary care contacts
• All primary care contacts
• Time to discontinuation of initial therapy
• Time to addition of a further COPD controller medication
• Time to first moderate/severe exacerbation
• Time to first severe exacerbation (i.e., hospitalisation)
Other endpoints
• Number of hospitalisations	• Adherence is assessed based on analysis of medications (prescribed, dispensed and collected) and use of the MARS-A at visit 2 and visit 6/early withdrawal visit
• Number of days in hospital
• Total number of respiratory-related home visits (including out-of-hours calls) and telephone consultations
• CAT: disease management, quality of life
• EQ-5D
• Adherence to study medication
• Number of salbutamol inhalers collected by the patients from study-enrolled community pharmacies over the 12-month treatment period

CAT COPD Assessment Test, COPD chronic obstructive pulmonary disease, EQ-5D EuroQol Questionnaire, MARS-A Medication Adherence Report Scale for Asthma, NHS National Health Service