Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Retrospective, Real-World Effectiveness
Brief summary
A retrospective real-world data study, assessing the relationship between the timing of Budesonide/Glycopyrrolate/Formoterol initiation following an exacerbation and the occurrence of subsequent exacerbations, severe cardiopulmonary events and other real-world outcomes in Japan
Interventions
DRUGBGF
BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of COPD (at any position) before or on the index date * 1 dispensation of BGF on or following the launch date of BGF in Japan * Patients must have evidence of at least one qualifying COPD exacerbation event, which qualify the initiation of triple therapy. The exacerbation event must occur within the 12-month period preceding BGF initiation and on or after BGF launch in Japan (i.e., 04 September 2019). The earliest qualifying COPD exacerbation event will be set as the index date. * 12 months of continuous health plan enrollment preceding the qualifying COPD exacerbation date * 1 day of continuous enrollment following the qualifying COPD exacerbation date * Age ≥ 40 years on the qualifying COPD exacerbation date
Exclusion criteria
* Presence of ≥ 2 records of respiratory cancer diagnoses occurring at least 1 month apart during the 12-month baseline period preceding the qualifying COPD exacerbation or during the follow-up period * Presence of ≥ 1 dispensation of SITT during the 12-month baseline period preceding the index date through BGF initiation * Patients who only have 1 moderate COPD exacerbation in 12-months period prior to BGF initiation with no dispensation of long-acting inhaled COPD maintenance treatment during the 12-months baseline period preceding the qualifying COPD exacerbation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized COPD Exacerbation Event Rate | Annualized rates from index exacerbation through end of data availability; median follow-up 713 days | Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability with a median follow-up of 713 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Cardiopulmonary Event Rate | Annualized rates from index exacerbation through end of data availability with median follow-up of 713 days | Annualized rates of cardiopulmonary events observed from index date (qualifying exacerbation event) through study completion (until end of data availability) with median follow-up time of 713 days. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to and rate of all-cause mortality | Annualized incidence of mortality from index exacerbation through end of data availability; median follow-up 713 days | Annualized incidence of all-cause mortality observed from index date (qualifying exacerbation event) through study completion (until end of data availability with median follow-up time of 713 days. |
Countries
United States
Outcome results
None listed