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NCT06744374 · ClinicalTrials.gov registry record
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)
A clinical trial, sponsored by AstraZeneca.
- Completed
- Registry status
- 22,369
- Enrollment target
NCT06744374: Completed study, sponsored by AstraZeneca.
NCT06744374 is a clinical trial that has completed, run by AstraZeneca. The registered enrollment target is 22,369 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06744374 has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- 22,369 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG BGF
- DRUG MITT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22,369 participants |
| Start Date | 2024-02-29 |
| Est. Completion | 2024-03-30 |
What the finished NCT06744374 record still lists
NCT06744374 is an observational study that tracks outcomes without assigning an intervention. Its 22,369 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which BGF is the first listed.
NCT06744374 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06744374 about?
NCT06744374 is a clinical study titled "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)". 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 cardiopulmonar...
What is the current status of trial NCT06744374?
This trial is currently completed. The enrollment target is 22,369 participants. The study started on 2024-02-29. Estimated completion is 2024-03-30.
What interventions are being tested in trial NCT06744374?
The interventions under investigation include: BGF (DRUG), MITT (DRUG).
Who is sponsoring clinical trial NCT06744374?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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