COPD
Conditions
Keywords
COPD;, readmissions;, maintenance therapy;, triple therapy;, real-world evidence;, hospital discharge;, mortality;, cardiopulmonary events,, exacerbations
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.
Interventions
DRUGBudesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily.
2 inhalations twice daily administered by oral inhalation, from a metered dose inhaler, over a 12-month follow-up period.
OTHERExternal Comparator
Received any inhaled therapy, excluding triple inhaled maintenance therapy, during index hospitalization and refilled within 30 days before or after discharge from index hospitalization
Sponsors
Iqvia Pty Ltd
Premier Inc
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 100 Years
Healthy volunteers
No
Inclusion 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: 1. Willingness to use Breztri as an inhaled maintenance medication as prescribed by their physician. 2. Willingness and ability to sign informed consent during index admission and before discharge. 3. Availability of home-based access to telephone calls. 4. Availability of home-based access to the internet for PRO measurement and inhaler training materials. 5. Willingness to be contacted by a qualified medical professional for safety monitoring. 6. 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 7. Physician decision that patient is eligible for treatment with Breztri according to the approved USPI. 8. 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: 1. 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with an all-cause readmission | 90 days post-index discharge |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| proportion of patients experiencing COPD severe exacerbations | 30 days, 90 days, and 1 year post-index discharge |
| Number of all-cause readmissions | 90 days 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 |
| time to all-cause mortality | 1 year post-index discharge |
| number of COPD moderate/severe exacerbations per time period | 30 days, 90 days, and 1 year post-index discharge |
Outcome results
None listed