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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: BGF

• Registration Number: NCT06742736
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-31
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13000

Inclusion Criteria

• 1 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

• 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 event

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prompt	BGF	PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION
DELAYED	BGF	PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION
VERY DELAYED	BGF	PATIENTS INITIATING BGF WITHIN 181-365 DAYS OF EXACERBATION

Primary Outcome Measures

Name	Time	Method
Annualized COPD Exacerbation Event Rate	Annualized rates from index exacerbation through end of data availability, mean follow-up 462 days	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

Secondary Outcome Measures

Name	Time	Method
Annualized Cardiopulmonary Event Rate	Annualized rates from index exacerbation through end of data availability; mean follow-up 462 days	Annualized rates of cardiopulmonary events observed from index date (qualifying exacerbation event) through study completion (until end of data availability)

Trial Locations

Locations (1)

AstraZeneca; 🇺🇸 Wilmington, Delaware, United States