Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation

AstraZeneca

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Study type: Observational

Funder types: Industry

Identifiers

NCT07414134

D5980R00121

Details and patient eligibility

About

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.

Enrollment: 3,598 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,598 participants in 2 patient groups

Prompt

Description:

Patients initiating BGF within 30-days of exacerbation

Treatment:

Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Delayed

Description:

Patients initiating BGF within 31-180 days of exacerbation

Treatment:

Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL