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

Exclusion Criteria

• Patients are included into the study if they meet the following criteria :
• 1 Adults aged 40 years and above as of the index hospitalization admission date (for the intervention arm only).
• 2 Primary or secondary diagnosis of COPD as documented in the database on or before admission.
• 3 Hospital admission for a COPD exacerbation (primary or secondary cause) (ie, the index admission).
• 4 Availability of at least 6 months of data in the PHD-LRx-Dx database prior to the index admission (for the comparator arm only).
• 5 Additional inclusion criteria for the interventional arm:
• (a) Willingness to use Breztri as an inhaled maintenance medication as prescribed by their physician.
• (b) Willingness and ability to sign informed consent during index admission and before discharge.
• (c) Availability of home-based access to telephone calls.
• (d) Availability of home-based access to the internet for PRO measurement and inhaler training materials.
• (e) Willingness to be contacted by a qualified medical professional for safety monitoring.
• (f) 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
• (g) Physician decision that patient is eligible for treatment with Breztri according to the approved USPI.
• (h) Any females of childbearing potential must be using a form of highly effective methods of contraception and have a negative urine pregnancy test result
• 6 Additional inclusion criterion for the comparator arm:
• (a) 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.
• 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:
• (a) Discharged on a triple inhaled maintenance therapy in addition to Breztri.
• (b) 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.
• (c) 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.