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)

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: BGF; Drug: MITT

• Registration Number: NCT06744374
• Lead Sponsor: AstraZeneca

Brief Summary

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 li...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-02-29
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22369

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD Patients	BGF	COPD patients initiating BGF or MITT
COPD Patients	MITT	COPD patients initiating BGF or MITT

Primary Outcome Measures

Name	Time	Method
Time to and rate of all-cause mortality	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.

Secondary Outcome Measures

Name	Time	Method
Time to and rate of cardiopulmonary events	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

Trial Locations

Locations (1)

AstraZeneca; 🇺🇸 Wilmington, Delaware, United States