Status:
WITHDRAWN
IKANOS: Breztri Maintenance Versus Any Non-Triple Inhaled Therapy After Hospitalization for a COPD Exacerbation in the US
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Iqvia Pty Ltd
Premier Inc
Conditions:
COPD
Eligibility:
All Genders
40-100 years
Phase:
PHASE4
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 read...
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 Hospitalizat...
Eligibility Criteria
Inclusion
- Patients are included into the study if they meet the following criteria :
- Adults aged 40 years and above as of the index hospitalization admission date (for the intervention arm only).
- Primary or secondary diagnosis of COPD as documented in the database on or before admission.
- Hospital admission for a COPD exacerbation (primary or secondary cause) (ie, the index admission).
- Availability of at least 6 months of data in the PHD-LRx-Dx database prior to the index admission (for the comparator arm only).
- Additional inclusion criteria for the interventional arm:
- 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
- Additional inclusion criterion for the comparator arm:
- 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.
- SABA.
- SAMA.
- Other inhaled COPD therapy not classified as triple therapy.
- Exclusion Criteria:
- 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.
- Additional exclusion criteria for the interventional arm:
- 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.
Exclusion
Key Trial Info
Start Date :
January 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05970263
Start Date
January 19 2024
End Date
December 31 2025
Last Update
February 1 2024
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