EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MITOS: EROS+CP US Study)
Completed
Conditions studied: Pulmonary Disease, Chronic Obstructive
In brief
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
Key facts
- Study ID
- NCT06742736
- Run by
- AstraZeneca
- People needed
- 13000
- Starts
- 2024-05-31
- Expected to finish
- 2024-09-30
- Last updated by the study team
- 2025-08-07
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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
Where it is running
- AstraZeneca — Wilmington, Delaware, United States
Full record on ClinicalTrials.gov
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