EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MITOS: EROS+CP US Study)

NCT06742736 | Completed

• 1 other identifier: D5980R00095
• Study Type: observational
• Target: 13,000
• Locations: 1 country
• Sites: 1

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 the United States

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; Chronic Obstructive Pulmonary Disease; Retrospective; Real-World Effectiveness

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; mean follow-up 462 days

  Annualized rates from index exacerbation through end of data availability, mean follow-up 462 days

Secondary Outcomes (1)

• Annualized Cardiopulmonary Event Rate

  Annualized rates from index exacerbation through end of data availability; mean follow-up 462 days

Other Outcomes (1)

• Annualized rate of all-cause mortality

  Annualized incidence of mortality during follow-up period until end of data availability; mean follow-up 462 days

Study Arms (3)

Prompt

PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION

Drug: BGF

DELAYED

PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION

Drug: BGF

VERY DELAYED

PATIENTS INITIATING BGF WITHIN 181-365 DAYS OF EXACERBATION

Drug: BGF

Interventions

BGF DRUG

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Also known as: BREZTRI

DELAYED; Prompt; VERY DELAYED

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 overall sample will include adult (aged 40+) COPD patients who have experienced a qualifying COPD exacerbation and eventually received treatment with BGF. Patients should not have prior single inhaler triple therapy (SITT) use during the 12-month period-baseline prior to the qualifying index exacerbation and prior to initiating BGF treatment.

You may qualify if:

• prescription(s) fill for BGF on or following July 24, 2020 (date of BGF approval in the United States)
• Patients must have evidence a qualifying exacerbation events which, per local or global guidelines, would qualify a patient to have treatment escalated or initiated to triple therapy. The qualifying exacerbation event must occur within the 12-month period preceding the initiation of BGF but occurring on or following local BGF commercial availability (July 24, 2020) and includes either of the following
• months of continuous health plan enrollment preceding the qualifying index exacerbation event date ('baseline' period)
• day of continuous enrollment following the qualifying index exacerbation date
• Age ≥ 40 years on the qualifying index exacerbation event

You may not qualify if:

• Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline or follow-up periods
• Presence of interstitial fibrosis, sarcoidosis, or pulmonary embolism diagnoses during the baseline or follow-up periods
• Presence of triple therapy SITT during the baseline period through BGF initiation

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

AstraZeneca

Wilmington, Delaware, 19803, United States

Location

Related Links

• D5980R00095 Redacted CSR Synopsis

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

• Michael Pollack, MS

  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: December 16, 2024
• First Posted: December 19, 2024
• Study Start: May 31, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

US (1)