IKANOS: Breztri Maintenance Versus Any Non-Triple Inhaled Therapy After Hospitalization for a COPD Exacerbation in the US

NCT05970263 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: D5980C00034
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate whether prompt initiation and maintenance of Breztri (a triple therapy) following a severe COPD exacerbation hospitalization, is associated with a lower risk of all-cause readmissions at 90 days post-discharge, compared to receiving any non-triple inhaled therapy.

Conditions

COPD

Keywords

COPD;; readmissions;; maintenance therapy;; triple therapy;; real-world evidence;; hospital discharge;; mortality;; cardiopulmonary events,; exacerbations

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with an all-cause readmission

  90 days post-index discharge

Secondary Outcomes (12)

• Number of all-cause readmissions

  90 days post-index discharge

• Time to first all-cause readmission

  1 year post-index discharge

• Proportion of patients with all-cause readmissions

  30 days and 1 year post-index discharge

• number of all-cause readmissions per time period

  30 days and 1 year post-index discharge

• proportion of patients experiencing COPD moderate/severe exacerbations

  30 days, 90 days and 1 year post-index discharge

Study Arms (2)

Breztri

EXPERIMENTAL

1\. Interventional Arm: patients receive : 1. First dose of Breztri during hospitalization and discharge with 7-day Breztri inhaler 2. Breztri refills to cover 12-month follow-up period, mailed in 90-day supply from a central pharmacy. Emergency resupply is also available if needed.

Drug: Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily.

External Comparator - Non-Triple

OTHER

2\. External Comparator Arm: patient who receive any non-triple inhaled therapy following a hospitalization for severe COPD exacerbation. This arm will be constructed of de-Identified patient.

Other: External Comparator

Interventions

Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily. DRUG

2 inhalations twice daily administered by oral inhalation, from a metered dose inhaler, over a 12-month follow-up period.

Breztri

External Comparator OTHER

Received any inhaled therapy, excluding triple inhaled maintenance therapy, during index hospitalization and refilled within 30 days before or after discharge from index hospitalization

External Comparator - Non-Triple

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to use Breztri as an inhaled maintenance medication as prescribed by their physician.
• Willingness and ability to sign informed consent during index admission and before discharge.
• Availability of home-based access to telephone calls.
• Availability of home-based access to the internet for PRO measurement and inhaler training materials.
• Willingness to be contacted by a qualified medical professional for safety monitoring.
• Willingness and ability to participate, on their own or through the assistance of their caregivers, in remote, online patient-reported outcome measurement at designated intervals
• Physician decision that patient is eligible for treatment with Breztri according to the approved USPI.
• Any females of childbearing potential must be using a form of highly effective methods of contraception and have a negative urine pregnancy test result
• Received non-triple inhaled therapy for COPD within 30 days prior to discharge or up to 30 days post-discharge, including:
• ICS/LABA.
• LABA/LAMA.
• ICS.
• LABA.
• LAMA.
• SABA/SAMA.

You may not qualify if:

• Patients are excluded from the study if they meet any of the following criteria:
• Having received triple inhaled maintenance therapy (fixed-dose, or open) for COPD or other indications 6 months prior to index admission.
• Any documented use of respiratory biologics 6 months prior to index admission.
• Patients on palliative care, including hospice.
• Discharge to institutional care other than a rehabilitation facility (eg, other hospital, or similar). Patients discharged to rehabilitation facility are eligible to participate. Note: Because patients are enrolled in the intervention arm prior to discharge, this criterion should be assessed using the working knowledge of the treating physician at the time of patient enrollment.
• Mortality on or before index discharge.
• Conditions including lung surgery (excluding thoracentesis or chest tube insertion or thoracostomy) in 6 months prior to index admission, history of pulmonary lobectomy, cystic fibrosis, interstitial lung disease, lung cancer, or alpha-1 antitrypsin deficiency (A1ATD) inducing severe disease as recorded in the PHD-LRx-Dx database.
• For females only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding or planning to become pregnant in the year following index discharge.
• Discharged on a triple inhaled maintenance therapy in addition to Breztri.
• Patients who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinicanticholinergics, or any component of the MDI.
• Patients who are clinically unstable, ie, still admitted within the intensive care unit,with ongoing dyspnea, requiring vasopressors or round-the-clock positive airway pressure ventilatory support.

Sponsors & Collaborators

• AstraZeneca: lead
• Iqvia Pty Ltd: collaborator
• Premier Inc: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Glycopyrrolate; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols

Study Officials

• Igor Barjaktarevic, MD, PhD

  David Geffen School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: August 1, 2023
• Study Start: January 19, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at