COPDPhase 4IKANOSNCT05970263
IKANOS: Breztri Maintenance Versus Any Non-Triple Inhaled Therapy After Hospitalization for a COPD Exacerbation in the US
A Phase 4 study testing Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily. and External Comparator in people with COPD, run by AstraZeneca.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- COPD
- What is being tested?
- Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily. and External Comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Jan 2024to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
About this study
Official title: IKANOS: 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
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily., External Comparator
- Keywords
- COPD;, readmissions;, maintenance therapy;, triple therapy;, real-world evidence;, hospital discharge;, mortality;, cardiopulmonary events,, exacerbations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
External ComparatorOther
Received any inhaled therapy, excluding triple inhaled maintenance therapy, during index hospitalization and refilled within 30 days before or after discharge from index hospitalization
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: External Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with an all-cause readmission
Measured: 90 days post-index discharge
Secondary outcomes (12)
Number of all-cause readmissions
Measured: 90 days post-index discharge
Time to first all-cause readmission
Measured: 1 year post-index discharge
Proportion of patients with all-cause readmissions
Measured: 30 days and 1 year post-index discharge
number of all-cause readmissions per time period
Measured: 30 days and 1 year post-index discharge
proportion of patients experiencing COPD moderate/severe exacerbations
Measured: 30 days, 90 days and 1 year post-index discharge
proportion of patients experiencing COPD severe exacerbations
Measured: 30 days, 90 days, and 1 year post-index discharge
number of COPD moderate/severe exacerbations per time period
Measured: 30 days, 90 days, and 1 year post-index discharge
number of COPD severe exacerbations per time period
Measured: 30 days, 90 days, and 1 year post-index discharge
time to first COPD moderate/severe exacerbations
Measured: 1 year post-index discharge
time to first COPD severe exacerbations
Measured: 1 year post-index discharge
proportion of patients experiencing all-cause mortality
Measured: 90 days and 1 year post-index discharge
time to all-cause mortality
Measured: 1 year post-index discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start19 Jan 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd, Premier Inc
- Responsible party
- Sponsor
- Investigators
- Igor Barjaktarevic, MD, PhD, Principal investigator, David Geffen School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970263
- Sponsor's protocol ID
- D5980C00034
- Acronym
- IKANOS
- Status last verified
- Jan 2024
- First submitted
- 27 Jun 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IKANOS: 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
- ClinicalTrials.gov ID
- NCT05970263
- Acronym / sponsor ID
- IKANOS / D5980C00034
- Conditions
- COPD
- Keywords
- COPD;, readmissions;, maintenance therapy;, triple therapy;, real-world evidence;, hospital discharge;, mortality;, cardiopulmonary events,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd, Premier Inc
- Study start
- 19 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breztri | Experimental | Drug: 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 | Other | Other: External Comparator2. 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. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide/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. | Drug | Breztri |
| External ComparatorReceived any inhaled therapy, excluding triple inhaled maintenance therapy, during index hospitalization and refilled within 30 days before or after discharge from index hospitalization | Other | External Comparator - Non-Triple |
Primary outcome
Proportion of patients with an all-cause readmission
Time frame: 90 days post-index discharge
12 secondary outcomes
Number of all-cause readmissions
Time frame: 90 days post-index discharge
Time to first all-cause readmission
Time frame: 1 year post-index discharge
Proportion of patients with all-cause readmissions
Time frame: 30 days and 1 year post-index discharge
number of all-cause readmissions per time period
Time frame: 30 days and 1 year post-index discharge
proportion of patients experiencing COPD moderate/severe exacerbations
Time frame: 30 days, 90 days and 1 year post-index discharge
proportion of patients experiencing COPD severe exacerbations
Time frame: 30 days, 90 days, and 1 year post-index discharge
number of COPD moderate/severe exacerbations per time period
Time frame: 30 days, 90 days, and 1 year post-index discharge
number of COPD severe exacerbations per time period
Time frame: 30 days, 90 days, and 1 year post-index discharge
time to first COPD moderate/severe exacerbations
Time frame: 1 year post-index discharge
time to first COPD severe exacerbations
Time frame: 1 year post-index discharge
proportion of patients experiencing all-cause mortality
Time frame: 90 days and 1 year post-index discharge
time to all-cause mortality
Time frame: 1 year post-index discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Barjaktarevic, MD, PhD principal investigator
David Geffen School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily. and External Comparator in people with COPD, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with an all-cause readmission (time frame: 90 days post-index discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.