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

NCT07414134 | Completed

• 1 other identifier: D5980R00121
• Study Type: observational
• Target: 3,598
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Annualized COPD Exacerbation Event Rate

  Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability

  180 days

Secondary Outcomes (2)

• Annualized Cardiopulmonary Event Rate

  180 days

• Annualized rate of all-cause mortality

  180 days

Study Arms (2)

Prompt

Patients initiating BGF within 30-days of exacerbation

Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Delayed

Patients initiating BGF within 31-180 days of exacerbation

Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Interventions

BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL DRUG

This is a real-world observational study evaluating the timing of BGF, post discharge.

Delayed; Prompt

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is selected to allow a clear comparison of outcomes according to the timing of BGF initiation following a severe COPD exacerbation. The overall sample will include adult (aged ≥40) patients with COPD who have experienced a qualifying severe COPD exacerbation and received treatment with BGF within 6 months. Patients should not have prior single inhaler triple therapy (SITT) use during the available history of patients' data preceding the qualifying index severe exacerbation and prior to initiating BGF treatment.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

AstraZeneca

Gaithersburg, Maryland, 20878, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Della Varghese, PhD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: February 17, 2026
• Study Start: October 31, 2025
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

Locations

US (1)