A Comparative Effectiveness Study of Mortality Outcomes and Related Cardiopulmonary Events Among a Cohort of Chronic Obstructive Pulmonary Disease (COPD) Patients Who Initiate Breztri and Multiple Inhaler Triple Therapy (MITT) in the United States (US)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22369 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-03-30

Brief Summary

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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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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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COPD Patients

COPD patients initiating BGF or MITT

BGF

Intervention Type DRUG

Budesonide/glycopyrrolate/formoterol fumarate

MITT

Intervention Type DRUG

Multiple-inhaler triple therapy

Interventions

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BGF

Budesonide/glycopyrrolate/formoterol fumarate

Intervention Type DRUG

MITT

Multiple-inhaler triple therapy

Intervention Type DRUG

Other Intervention Names

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Breztri Open triple therapy combination

Eligibility Criteria

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Inclusion Criteria

* 1 initial prescription for BGF or MITT starting October 1, 2020 through to the latest available data update, AND

* Age ≥40 years on date of first prescription for BGF or MITT episode, AND
* Continuous medical and pharmacy health plan eligibility for ≥12-months (365 days) prior to first prescription for BGF or MITT AND
* 2 medical claims with diagnoses for COPD at least 30 days apart occurring on or anytime in the patient's available 24-month history before the first BGF prescription or MITT episode, with one diagnosis occurring in the immediate 12-month period prior to or on initiation of BGF or MITT

Exclusion Criteria

* Age \<40 at time of treatment initiation
* Invalid or unknown gender
* If death date occurs prior to or on study index date
* \<12 months (365 days) of medical and pharmacy health plan eligibility/coverage prior treatment initiation
* Presence of ≥1 prescription claim for any triple therapy during the patient's entire available baseline history (BGF, FF/UMEC/VI or MITT)
* "potential MITT use" in baseline, MITT for baseline purposes will be defined as ≥1 days continuous days where all three MITT components (ICS, LABA, LAMA) are observed in combination (dual + monotherapy) or as three separate monotherapy components
* History of any of the following conditions, procedures or events during the immediate baseline 12-month period: (a) ≥1 medical claim (i.e., office, ED or hospital) in any position with a diagnosis for alpha-1-antitrypsin deficiency, interstitial fibrosis, lung cancer, pulmonary embolism, sarcoidosis; (b) ≥1 medical claim for hospice services; (c) Any medical Bill Type Code (BILL\_TYPE\_CODE ) starting with 81 or 82; or Revenue codes (RVNU\_CD): 0651-0659; (d) ≥1 medical claim with a diagnosis code of encounter related to clinical trial participation (Z00.6) at any point during the study period (including both baseline and follow-up periods)

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No