Clinical trial NCT06742736: EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MITOS: EROS+CP US Study)
Official title: EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE INITIATING BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL (MITOS: EROS+CP US Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Chronic Obstructive Pulmonary Disease
Retrospective
Real-World Effectiveness
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 13000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Annualized COPD Exacerbation Event Rate
timeFrame: Annualized rates from index exacerbation through end of data availability, mean follow-up 462 days
Secondary outcomes:
measure: Annualized Cardiopulmonary Event Rate
timeFrame: Annualized rates from index exacerbation through end of data availability; mean follow-up 462 days
Other outcomes:
measure: Annualized rate of all-cause mortality
timeFrame: Annualized incidence of mortality during follow-up period until end of data availability; mean follow-up 462 days
Locations:
city: Wilmington
country: United States
facility: AstraZeneca
state: Delaware
Study officials:
affiliation: AstraZeneca
name: Michael Pollack, MS
role: STUDY_DIRECTOR
References: