Characteristics and Treatment Patterns of Patients with Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study.

25/10/2019
14/07/2021
EU PAS number:
EUPAS31940
Study
Planned
Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
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

350000
Study design details

Main study objective

The primary objectives of the study are to use US and UK data to describe the characteristics of COPD patients according to various demographic, lifestyle, clinical, and medication use at the time of diagnosis, at the time of initiation of first mantenance therapy and at the time of initiation of second maintenance therapy

Outcomes

Patient characteristics, include various demographic, lifestyle, clinical, and medication characteristics will be reported at three points in time: 1) COPD claim confirming diagnosis date (Cohort Entry Date), 2) Date of initiation of first maintenance therapy (1st Treatment Index Date), overall and stratified by therapy category, 3)

Data analysis plan

• All covariates will be reported as mean (SD) and/or median (IQR) for continuous variables and counts and frequency (%) for categorical variables.