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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2024-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Prompt

PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION

BGF

Intervention Type DRUG

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

DELAYED

PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION

BGF

Intervention Type DRUG

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

VERY DELAYED

PATIENTS INITIATING BGF WITHIN 181-365 DAYS OF EXACERBATION

BGF

Intervention Type DRUG

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Interventions

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BGF

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Intervention Type DRUG

Other Intervention Names

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BREZTRI

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No