Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Chronic obstructive pulmonary disease
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

25000
Study design details

Main study objective

1. To examine whether the effectiveness of triple therapy is superior to that of dual bronchodilation (LAMA+LABA), in terms of reducing COPD-related exacerbations2. To study the potential heterogeneity of the effectiveness driven by patient’s and therapy characteristics 3. To establish the effectiveness of triple therapy on reducing long-term lung function decline

Outcomes

1. COPD exacerbations: number in first year and time to first event2. Average decline in forced expiratory volume in first second FEV1 per year, 1. Acute courses of oral corticosteroids (number in first year and time to first event) 2. Antibiotic prescriptions following lower respiratory consultation (number in first year and time to first event)3. Time to first hospitalisation with COPD as primary diagnosis4. Time to first A&E attendance related to COPD5. Time to first pneumonia diagnosis6. mMRC score within 18 months

Data analysis plan

Patients will be matched between treatment groups, according to relevant demographic and clinical characteristics.Conditional negative binomial regression will be performed to estimate adjusted Rate Ratios (RR) with 95% confidence intervals (CI) for the effect of treatment on outcomes that involve counted numbers of events over fixed time periods.An intention-to-treat time-to-event analysis will be performed to analyse the association between treatment and time to the first outcome event during follow-up after ID with right censoring at the time of death or loss to follow-up. Stratified Cox regression will be performed with time to the first event as the outcome variable to estimate Hazard Ratios (HR) with 95% CI of the treatment effect. Effect modification by patient and therapy characteristics will be studied by including interaction terms into the model.For objective 3, the change in FEV1 over time will be analysed using a multilevel model for change.