Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572228
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Efficacy of Dupilumab Added to Medium Dose Inhaled CorticosteroidLong-acting Beta-agonist ICSLABA in Comparison to ICS Dose Escalation to High Dose ICSLABA in Adolescent and Adult Patients With Uncontrolled Asthma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
AIM4 Next Step - Asthma Uncontrolled With ICS in Medium Dose GINA 4 Next Step Efficacy of Dupilumab Added to Medium Dose ICSLABA in Comparison to ICS Dose Escalation to High Dose ICSLABA in Patients With Uncontrolled Asthma
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIM4Next Step
Brief Summary:
This study is researching a drug called dupilumab The study is focused on patients who have uncontrolled asthma Asthma is a condition where the airways narrow and swell making it difficult to breathe Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication
The aim of the study is to see which regimen is more effective taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist referred to as an ICSLABA Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist referred to as a LAMA if they are already receiving a LAMA
The study is also looking at
What side effects may happen from taking dupilumab
The aim of the study is to see which regimen is more effective taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist referred to as an ICSLABA Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist referred to as a LAMA if they are already receiving a LAMA
The study is also looking at
What side effects may happen from taking dupilumab
Detailed Description:
This study is a Phase 3b in Canada Minors will not be enrolled in Denmark
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None