EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE INITIATING BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL (MITOS: EROS+CP Japan Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 3,402
- 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 Japan
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
- •Diagnosis of COPD (at any position) before or on the index date
- •1 dispensation of BGF on or following the launch date of BGF in Japan
- •Patients must have evidence of at least one qualifying COPD exacerbation event, which qualify the initiation of triple therapy. The exacerbation event must occur within the 12-month period preceding BGF initiation and on or after BGF launch in Japan (i.e., 04 September 2019). The earliest qualifying COPD exacerbation event will be set as the index date.
- •12 months of continuous health plan enrollment preceding the qualifying COPD exacerbation date
- •1 day of continuous enrollment following the qualifying COPD exacerbation date
- •Age ≥ 40 years on the qualifying COPD exacerbation date
Exclusion Criteria
- •Presence of ≥ 2 records of respiratory cancer diagnoses occurring at least 1 month apart during the 12-month baseline period preceding the qualifying COPD exacerbation or during the follow-up period
- •Presence of ≥ 1 dispensation of SITT during the 12-month baseline period preceding the index date through BGF initiation
- •Patients who only have 1 moderate COPD exacerbation in 12-months period prior to BGF initiation with no dispensation of long-acting inhaled COPD maintenance treatment during the 12-months baseline period preceding the qualifying COPD exacerbation.
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 BETWEEN 181 AND 365 DAYS AFTER EXACERBATION
Intervention: BGF (Drug)
Outcomes
Primary Outcomes
Annualized COPD Exacerbation Event Rate
Time Frame: Annualized rates from index exacerbation through end of data availability; median follow-up 713 days
Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability with a median follow-up of 713 days
Secondary Outcomes
- Annualized Cardiopulmonary Event Rate(Annualized rates from index exacerbation through end of data availability with median follow-up of 713 days)