Study identifier:D5980R00098
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
An Observational, Non-Interventional Comparative Effectiveness Study of Mortality Outcomes and Related Cardiopulmonary Events Among a Cohort of Commercially Insured Chronic Obstructive Pulmonary Disease (COPD) Patients who Initiate Breztri and Multiple Inhaler Triple Therapy (MITT) in the United States (US)
Pulmonary Disease, Chronic Obstructive
Phase 4
No
BGF, MITT
All
22369
Observational
40 Years - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
Patients with chronic obstructive pulmonary disease (COPD) have elevated risk of mortality and cardiopulmonary events, particularly following exacerbations. While single inhaler triple therapies (SITTs), such as budesonide/glycopyrrolate/formoterol fumarate (BGF), reduce mortality and cardiopulmonary event risk versus dual bronchodilator therapy, there is limited evidence comparing outcomes associated with SITTs versus multiple inhaler triple therapies (MITTs). SKOPOS-MAZI was a retrospective comparative effectiveness study in patients with COPD aged ≥40 years using US administrative claims data from Optum’s de-identified Clinformatics® Data Mart Database. The primary and secondary endpoints were time to all-cause mortality (ACM) and time to first severe cardiopulmonary event following initiation of BGF or MITT (identification period: October 1, 2020–June 30, 2023; index date: first prescription fill). Relative hazards of outcomes were assessed until a censoring event using Cox proportional hazards models, with inverse propensity treatment weighting accounting for between-group imbalances (standardized mean difference >0.1) in baseline characteristics.
Location
Location
Wilmington, Delaware, United States, 19803
Arms | Assigned Interventions |
---|---|
COPD Patients COPD patients initiating BGF or MITT | - |
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