AstraZeneca
Wilmington, Delaware, 19803, United States
NCT Number: NCT06744374
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.
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Notify Me40 year and older
All sexes
Observational
Wilmington, Delaware, 19803, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Budesonide/glycopyrrolate/formoterol fumarate
Other names: Breztri
Multiple-inhaler triple therapy
Other names: Open triple therapy combination
Time frame: During available follow-up; median 313 days
Time to and rate of all-cause mortality observed after initiation of BGF or MITT; all-cause mortality as defined by the available death information contained in the database.
Time frame: During available follow-up; median 313 days
Time to and rate of cardiopulmonary events observed during the follow-up period after initiation of BGF or MITT; cardiopulmonary events defined as a composite measure of severe (hospitalizations) COPD exacerbations and MACE-related events, and all-cause mortality
AstraZeneca
Industry
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)
Acronym: SKOPOS:MAZI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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