Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
This real-world retrospective study will use de-identified administrative claims data and will examine patients with a diagnosis of COPD who have experienced a qualifying severe disease exacerbation and received subsequent treatment with BGF. Agreed COPD patient data from the Inovalon MORE2 Registry® and Centers for Medicare & Medicaid Services (CMS) 100% Medicare Fee for Service (FFS) database spanning from January 1, 2021 to the most recently available data (September 30th, 2024 for the MORE2 database, and December 31st, 2023 for the Medicare FFS database) will be used for this analysis. All patients will be required to present at least one prescription claim for BGF. Patients will also be required to show evidence of a qualifying severe COPD exacerbation event during the 180-day period preceding initiation of BGF. Index date will be set as the date of discharge from the qualifying severe exacerbation event.
Interventions
DRUGBGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL
This is a real-world observational study evaluating the timing of BGF, post discharge.
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
* ≥ 1 prescription(s) fill for BGF on or following January 1, 2021 * Patients must have evidence of a severe qualifying exacerbation event. * The qualifying severe exacerbation event discharge date must occur within the 180-day period preceding the initiation of BGF for classification of patients into prompt or delayed initiators of BGF. * The discharge date of the first (earliest) observed qualifying index exacerbation event will be set as the index date * ≥ 12 months of continuous health plan enrollment preceding the qualifying index exacerbation event date (baseline period) * ≥ 1 day of continuous enrollment following the qualifying index exacerbation date * Age ≥ 40 years on the qualifying index exacerbation date
Exclusion criteria
* Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline period preceding the index date or entire follow-up period * Presence of ≥2 claims with a diagnosis of interstitial fibrosis or sarcoidosis diagnoses during the period preceding the index date or entire follow-up period * Presence of SITT at any time during the entire available history of patients' data preceding the index date through BGF initiation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized COPD Exacerbation Event Rate | 180 days | Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Cardiopulmonary Event Rate | 180 days | Annualized rates of cardiopulmonary events observed from index date (qualifying exacerbation event) through study completion (until end of data availability) |
| Annualized rate of all-cause mortality | 180 days | Annualized incidence of all-cause mortality observed from index date (qualifying exacerbation event) through study completion (until end of data availability) |
Countries
United States
Contacts
STUDY_DIRECTORDella Varghese, PhD
AstraZeneca
Outcome results
None listed