Skip to main content

Table 1 Study endpoints

From: The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in chronic obstructive pulmonary disease

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

  1. 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