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

Phase 4

Withdrawn

• Conditions: COPD
• Interventions: Drug: Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily.; Other: External Comparator

• Registration Number: NCT05970263
• Lead Sponsor: AstraZeneca

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.

Detailed Description

IKANOS is a prospective, open-label, minimally interventional Hybrid Study in the US Comparing Initiation of Breztri Maintenance versus Any Non-Triple Inhaled Therapy at Discharge after a Hospitalization for a COPD Exacerbation.

The interventional arm will be comprised of around 1000 patients for whom Breztri maintenance is prescribed, and the first dose is received prior to hospital discharge (the "index discharge") after a severe COPD exacerbation (the index admission).

At the end of the recruitment period of the interventional arm, the external comparator arm will be constructed from real-world data of patients contemporaneous with those in the interventional arm, from the same or similar integrated delivery network as the interventional arm and who are similar in key clinical and demographic characteristics.

Patients will be followed-up through their data and call center contact for up to 12 months.

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-07-21
• Study First Posted: 2023-08-01
• Status Verified: 2024-01
• Study Start: 2024-01-19
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Patients are excluded from the study if they meet any of the following criteria:

1. Having received triple inhaled maintenance therapy (fixed-dose, or open) for COPD or other indications 6 months prior to index admission.

2. Any documented use of respiratory biologics 6 months prior to index admission.

3. Patients on palliative care, including hospice.

4. 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.

5. Mortality on or before index discharge.

6. 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.

7. For females only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding or planning to become pregnant in the year following index discharge.

8. Additional exclusion criteria for the interventional arm:

   1. Discharged on a triple inhaled maintenance therapy in addition to Breztri.
   2. 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.
   3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breztri	Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily.	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.
External Comparator - Non-Triple	External Comparator	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with an all-cause readmission	90 days post-index discharge

Secondary Outcome Measures

Name	Time	Method
Number of all-cause readmissions	90 days post-index discharge
Time to first all-cause readmission	1 year post-index discharge
number of all-cause readmissions per time period	30 days and 1 year post-index discharge
Proportion of patients with all-cause readmissions	30 days and 1 year post-index discharge
time to all-cause mortality	1 year post-index discharge
proportion of patients experiencing COPD moderate/severe exacerbations	30 days, 90 days and 1 year post-index discharge
proportion of patients experiencing COPD severe exacerbations	30 days, 90 days, and 1 year post-index discharge
number of COPD moderate/severe exacerbations per time period	30 days, 90 days, and 1 year post-index discharge
number of COPD severe exacerbations per time period	30 days, 90 days, and 1 year post-index discharge
time to first COPD moderate/severe exacerbations	1 year post-index discharge
time to first COPD severe exacerbations	1 year post-index discharge
proportion of patients experiencing all-cause mortality	90 days and 1 year post-index discharge