Your session is about to expire
← Back to Search
Triple Therapy
Triple Inhaler Therapy for COPD After Hospitalization (IKANOS Trial)
Phase 4
Waitlist Available
Led By Adrian Paul J Rabe, DHPEd, MSc, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-index discharge
Awards & highlights
IKANOS Trial Summary
This trial looks at how a triple therapy affects COPD patients after hospital discharge to reduce readmissions.
Who is the study for?
This trial is for adults over 40 hospitalized due to severe COPD exacerbation, who've used non-triple inhaled therapy for COPD within the last month. Participants must be able to give consent, complete online health surveys, and have internet access. Exclusions include use of respiratory biologics or triple therapy prior to admission, certain lung conditions, pregnancy, breastfeeding plans within a year post-discharge, and hypersensitivity to Breztri components.Check my eligibility
What is being tested?
The study tests if starting on Breztri (a combination of budesonide/glycopyrrolate/formoterol) right after hospital discharge can reduce the risk of being readmitted within 90 days compared to other non-triple inhaled therapies for COPD.See study design
What are the potential side effects?
Breztri may cause side effects like pneumonia, thrush in your mouth and throat (a fungal infection), chest infections, coughing and hoarseness. It might also lead to an increased heart rate or changes in blood pressure.
IKANOS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIKANOS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post-index discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-index discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with an all-cause readmission
Secondary outcome measures
Number of all-cause readmissions
Proportion of patients with all-cause readmissions
Time to first all-cause readmission
+9 moreIKANOS Trial Design
2Treatment groups
Experimental Treatment
Group I: External Comparator - Non-TripleExperimental Treatment1 Intervention
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.
Group II: BreztriExperimental Treatment1 Intervention
1. Interventional Arm: patients receive :
First dose of Breztri during hospitalization and discharge with 7-day Breztri inhaler
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.
Find a Location
Who is running the clinical trial?
Premier IncIndustry Sponsor
1 Previous Clinical Trials
Iqvia Pty LtdIndustry Sponsor
107 Previous Clinical Trials
170,068 Total Patients Enrolled
Premier Inc.UNKNOWN
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have passed away either during or before leaving the hospital.You are currently using a specific type of inhaler medication in addition to Breztri.You are willing to use Breztri as a regular inhaler medication as instructed by your doctor.You have been using a specific type of inhaler treatment for chronic lung disease or other conditions in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Breztri
- Group 2: External Comparator - Non-Triple
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I able to join this clinical research initiative?
"Participants who are 40 and 100 years old with chronic obstructive pulmonary disease can be accepted into this trial. There is a goal of 1000 enrollees in total."
Answered by AI
Has Breztri been granted clearance by the FDA?
"This treatment is approved, therefore it has attained a score of 3 for safety."
Answered by AI
Are there multiple research centers conducting this investigation in North America?
"This research is currently happening in 7 centers, including those based out of Peoria, Salisbury and Mount Clemens. It would be prudent to select the facility nearest you in order to minimize travel-related challenges if chosen as a participant."
Answered by AI
Does this study have any age restrictions, particularly for younger participants?
"As outlined in the inclusion criteria, only individuals aged 40-100 will be considered for participation. There are 13 separate trials that cater to patients under 18 and 275 studies catering to those over 65."
Answered by AI
Is enrollment for this examination still available?
"Clinicaltrials.gov indicates that no new patients are being recruited for this trial at the present moment. This medical study was initially posted on September 25th 2023 and last updated on July 21st of the same year. Although not enrolling any additional participants, there are 281 other clinical trials currently in search of volunteer candidates."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger