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OpenTrials
Completed

NCT Number: NCT07414134

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

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AstraZeneca

Gaithersburg, Maryland, 20878, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Drug

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

Primary outcomes

  1. Annualized COPD Exacerbation Event Rate

    Time frame: 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 outcomes

  1. Annualized Cardiopulmonary Event Rate

    Time frame: 180 days

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

  2. Annualized rate of all-cause mortality

    Time frame: 180 days

    Annualized incidence of all-cause mortality observed from index date (qualifying exacerbation event) through study completion (until end of data availability)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation (MITOS:EROS+DISCHARGE)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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