EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE INITIATING BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL (MITOS: EROS+CP US Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 13,000
- Locations
- 1
- Primary Endpoint
- Annualized COPD Exacerbation Event Rate
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Prompt
PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION
Intervention: BGF (Drug)
DELAYED
PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION
Intervention: BGF (Drug)
VERY DELAYED
PATIENTS INITIATING BGF WITHIN 181-365 DAYS OF EXACERBATION
Intervention: BGF (Drug)
Outcomes
Primary Outcomes
Annualized COPD Exacerbation Event Rate
Time Frame: 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 Outcomes
- Annualized Cardiopulmonary Event Rate(Annualized rates from index exacerbation through end of data availability; mean follow-up 462 days)