Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04512521
Status:
RECRUITING
Last Update Posted:
2023-03-10
First Post:
2020-07-29
Brief Title:
Functional Lung MRI for Early Treatment Response Assessment for Patients With Eosinophilic Asthma
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
Official Title:
FUNLUM Functional Lung MRI for Early Treatment Response Assessment and Outcome Prediction for Patients With Severe Eosinophilic Asthma on Anti IL 5 Antibody Therapy
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUNLUM
Brief Summary:
Patients with severe eosinophilic asthma will be placed on biologics if they continue to be uncontrolled despite maximized inhalation therapy or if they are only controlled under oral corticosteroids Among biologics 80 of patients respond to treatment and improve clinically but approximately 20 are non-responders and up to date no established predictive factors for treatment response exist Among the responders about 30 respond very well so-called super responders the rest shows moderate improvements As the lung function one main criterion to evaluate treatment response improves in most patients with delay the response or non-response to treatment can only be reliably estimated after 4 to 12 months This can lead to prolonged use of medication in non-responders overtreatment on one hand and to unjustified and premature termination of therapy undertreatment on the other hand GINA report 2019
Functional lung MRI has the potential to show early changes in lung microstructure regional ventilation and perfusion and thus has the potential for early detection of therapy response Very promising results of dynamic regional ventilation and perfusion mapping using phase resolved functional lung PREFUL MRI have been shown recently
However if functional lung MRI can reliably detect treatment effects under Mepolizumab therapy and can help to predict a long-term patient outcome is still unknown As these findings could directly influence clinical decision making this question is of high clinical relevance
Functional lung MRI has the potential to show early changes in lung microstructure regional ventilation and perfusion and thus has the potential for early detection of therapy response Very promising results of dynamic regional ventilation and perfusion mapping using phase resolved functional lung PREFUL MRI have been shown recently
However if functional lung MRI can reliably detect treatment effects under Mepolizumab therapy and can help to predict a long-term patient outcome is still unknown As these findings could directly influence clinical decision making this question is of high clinical relevance
Detailed Description:
Asthma is a chronic disease and affects approximately 300 million people worldwide Of these patients 3-10 have severe asthma which is defined as asthma remaining uncontrolled despite treatment with high-dose inhaled glucocorticoids combined with other controllers long-acting β2-agonist long-acting antimuscarinic agent leukotriene receptor antagonist or theophylline andor treatment with systemic glucocorticoids for at least 6 months Severe asthma causes a high amount of medical expenses in asthma For patients suffering from severe uncontrolled asthma an IL-5 antibody mepolizumab has been approved for therapy when a type 2 inflammation was present Treatment is well tolerated and a significant reduction of exacerbations oral glucocorticoid use was reported Another IL-5 antibody reslizumab and an IL-5 receptor antibody benralizumab are available now
Patients with severe eosinophilic asthma will be placed on biologics if they continue to be uncontrolled under maximal therapy or if they are only controlled under oral corticosteroids Among biologics 80 of patients improve 20 are non-responders but there is no way to identify them early Among the responders about 30 respond very well so-called super responders the rest shows moderate improvements The main problems at the moment are that lung function improvements are only delayed the response or non-response can only be reliably estimated after 4 to 12 months This leads on the one hand to prolonged use of medication in non-responders overtreatment on the other hand to unjustified and premature termination of therapy undertreatment GINA report 2019
Study Rationale Functional lung MRI has the potential to show early changes in lung microstructure regional ventilation and perfusion and thus has the potential for early detection of therapy response Very promising results of dynamic regional ventilation and perfusion mapping using phase resolved functional lung PREFUL MRI have been shown recently This technique holds the promise to mature into a patient friendly sensitive MRI spirometry test with novel clinically relevant information to guide clinical decision making and improve patient monitoring PREFUL MRI typically uses standard 15T or 3T MRI equipment and is based on a routine gradient echo fast low angle shot FLASH sequence PREFUL is well suited also for children because it is a free breathing exam without the need for iv contrast and has a relatively short examination time The ventilation perfusion and dynamic flow-volume loop maps are reconstructed entirely after the image acquisition using complex registration and post processing algorithms developed and validated at Hannover Medical School Preliminary unpublished data show that PREFUL MRI may detect changes in regional ventilation 3 months after anti IL 5 antibody therapy treatment
However if functional lung MRI can reliably detect changes at 3 months of Mepolizumab treatment and can predict long term patient outcome is still unknown which is of high clinical relevance for future clinical decision making
The aim of this study is to examine if early treatment changes of Mepolizumab treatment can be detected at 3 months measured by functional lung MRI and predict clinical outcome at 12 months of treatment
Patients with severe eosinophilic asthma will be placed on biologics if they continue to be uncontrolled under maximal therapy or if they are only controlled under oral corticosteroids Among biologics 80 of patients improve 20 are non-responders but there is no way to identify them early Among the responders about 30 respond very well so-called super responders the rest shows moderate improvements The main problems at the moment are that lung function improvements are only delayed the response or non-response can only be reliably estimated after 4 to 12 months This leads on the one hand to prolonged use of medication in non-responders overtreatment on the other hand to unjustified and premature termination of therapy undertreatment GINA report 2019
Study Rationale Functional lung MRI has the potential to show early changes in lung microstructure regional ventilation and perfusion and thus has the potential for early detection of therapy response Very promising results of dynamic regional ventilation and perfusion mapping using phase resolved functional lung PREFUL MRI have been shown recently This technique holds the promise to mature into a patient friendly sensitive MRI spirometry test with novel clinically relevant information to guide clinical decision making and improve patient monitoring PREFUL MRI typically uses standard 15T or 3T MRI equipment and is based on a routine gradient echo fast low angle shot FLASH sequence PREFUL is well suited also for children because it is a free breathing exam without the need for iv contrast and has a relatively short examination time The ventilation perfusion and dynamic flow-volume loop maps are reconstructed entirely after the image acquisition using complex registration and post processing algorithms developed and validated at Hannover Medical School Preliminary unpublished data show that PREFUL MRI may detect changes in regional ventilation 3 months after anti IL 5 antibody therapy treatment
However if functional lung MRI can reliably detect changes at 3 months of Mepolizumab treatment and can predict long term patient outcome is still unknown which is of high clinical relevance for future clinical decision making
The aim of this study is to examine if early treatment changes of Mepolizumab treatment can be detected at 3 months measured by functional lung MRI and predict clinical outcome at 12 months of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 213598 | OTHER | GSK tracking number | None |