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

Completed
Conditions
Interventions
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

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
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
PromptBGFPATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION
DELAYEDBGFPATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION
VERY DELAYEDBGFPATIENTS INITIATING BGF WITHIN 181-365 DAYS OF EXACERBATION
Primary Outcome Measures
NameTimeMethod
Annualized COPD Exacerbation Event RateAnnualized 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
NameTimeMethod
Annualized Cardiopulmonary Event RateAnnualized 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

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