An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by AstraZeneca · Observational
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 22,369 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Commercially insured (including Medicare Advantage) patients diagnosed with COPD captured in the Optum CDM who are ≥40 years of age at the time of triple therapy initiation and who have at least two medical claim diagnoses for COPD (J41-J44) occurring on two separate occasions ≥30 days apart. Patients included will be new initiators of triple therapy (BGF or MITT) and have no record of a prescription fill for any triple therapy (including FF/UMEC/VI) during their entire available baseline history with at least the 12 months baseline history available prior to their first observed prescription for BGF or MITT
1 initial prescription for BGF or MITT starting October 1, 2020 through to the latest available data update, AND
Exclusion Criteria:
COPD patients initiating BGF or MITT
Drug: BGF · Drug: MITT
Budesonide/glycopyrrolate/formoterol fumarate
Also known as: Breztri
Multiple-inhaler triple therapy
Also known as: Open triple therapy combination
Time to and rate of all-cause mortality
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
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
Time frame: During available follow-up; median 313 days
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive→
AstraZeneca