Clinical trial NCT06744374: 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Retrospective
Observational
Triple Therapy
Cardiopulmonary
Mortality
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 22369
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Time to and rate of all-cause mortality
timeFrame: During available follow-up; median 313 days
Secondary outcomes:
measure: Time to and rate of cardiopulmonary events
timeFrame: During available follow-up; median 313 days
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: AstraZeneca
state: Delaware
Study officials:
affiliation: AstraZeneca
name: Michael Pollack, MS
role: STUDY_CHAIR
References: