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

12000
Study design details

Main study objective

To study the effectiveness of triple therapy on slowing down the rate of FEV1 decline in patients who were identified as being at high risk of rapid FEV1 decline by comparing the rate of FEV1 decline in patients during triple therapy with that of similar patients during minimal therapy or poor adherence to maintenance therapy

Outcomes

Lung function decline over time (Forced expiratory volume in one second), Occurrence of COPD exacerbations

Data analysis plan

Patients diagnosed with mild to moderate COPD, a history of smoking and repeated FEV1 measurements will be included. Initially, the study will validate an existing prediction model for FEV1 decline under minimal therapy, comparing observed and predicted FEV1 values. Differences between individual’s observed and predicted FEV1 values will be described after initiation of maintenance therapies. Analyses will be performed for patients with first maintenance therapy being a single inhaler, dual therapy or triple therapy, separately. In addition, patients initiated on triple therapy will be matched to similar patients on minimal therapy, based on potential confounders. A multilevel model for change (mixed linear regression) will be used to compare the rate of FEV1 decline between matched patients. Conditional negative binomial regression and stratified Cox-regression will be used to analyse differences in exacerbation rates and time to first COPD-related hospitalisation respectively.