Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567977
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-05
Brief Title:
TriMaximize A Multicentre Prospective Non-interventional Trial in Asthma Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
TriMaximize A Multicentre Prospective Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICSLABALAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Trimaximize PL
Brief Summary:
TriMaximize A multicentre prospective non-interventional trial monitoring therapy pathways of asthma patients treated with an extra-fine ICSLABALAMA single-inhaler triple therapy in a real-world setting and characterizing the effects on health-related outcomes
Detailed Description:
The goals of asthma therapy for all degrees of disease severity are minimising asthma symptoms maximising lung function and preventing asthma exacer-bations Despite the existing treatment options and differentiated guidelines 35 to 45 of the GINA 45 patients suffer from inadequately controlled symptoms To investigate the cause of unsatisfactory treatment results it is essential to monitor therapy pathways of asthma patients in a real-world set-ting Resulting data can be compared to therapy guidelines and generate hy-potheses for future clinical trials
Trimbow is a fixed triple therapy containing a long-acting muscarinic antago-nist LAMA glycopyrronium a long-acting beta-adrenergic agonist LABA formoterol and an inhaled corticosteroid ICS beclomethasone Trimbow MS medium strength contains 100 µg beclomethasone whereas Trimbow HS high strength contains 200 µg beclomethasone Both formulations are investigated in this study
Trimbow has shown major clinical benefits in randomised controlled trials However the effects of Trimbow on changes in patients symptom burden and quality of life adherence and clinical outcomes have not been yet as-sessed in a real-world asthma patient population
The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice
Secondary objectives include
To assess asthma control ACT
To assess quality of life Mini-AQLQ
To assess treatment adherence TAI
To analyse parameters of lung function
To analyse parameters of small airways disease FEF 25-75 RVTLC
To analyse parameters of asthma-related airway inflammation FeNO
To analyse parameters of persistent airways limitation reversibility testing FEV1FVC
To analyse the incidence and the severity of asthma exacerbations
To analyse the use of rescue medication
To analyse the use of systemic corticosteroids
To assess healthcare resource utilisation
To assess treatment satisfaction with Trimbow
To assess tolerability of Trimbow This is a non-interventional longitudinal international multicentre study with prospective data collection At baseline the patients medical history with spe-cial focus on asthma will be collected The study baseline visit is at the time point of start of treatment with Trimbow Trimbow treatment may have started up to a maximum of 4 weeks prior to inclusion of the patient into this NIS
The planned observational period per patient should be at least 52 weeks ob-servational period OP I of the study and can be extended to up to 3 years OP II of the study During the observational period data may be collected approximately every 3 months during the first year OP I of the study and thereafter every 6 months OP II of the study The present observational plan does not stipulate any study-related procedures or defined time points only data that are available within the current clinical routine will be collected as documented in the patients files
Trimbow is a fixed triple therapy containing a long-acting muscarinic antago-nist LAMA glycopyrronium a long-acting beta-adrenergic agonist LABA formoterol and an inhaled corticosteroid ICS beclomethasone Trimbow MS medium strength contains 100 µg beclomethasone whereas Trimbow HS high strength contains 200 µg beclomethasone Both formulations are investigated in this study
Trimbow has shown major clinical benefits in randomised controlled trials However the effects of Trimbow on changes in patients symptom burden and quality of life adherence and clinical outcomes have not been yet as-sessed in a real-world asthma patient population
The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice
Secondary objectives include
To assess asthma control ACT
To assess quality of life Mini-AQLQ
To assess treatment adherence TAI
To analyse parameters of lung function
To analyse parameters of small airways disease FEF 25-75 RVTLC
To analyse parameters of asthma-related airway inflammation FeNO
To analyse parameters of persistent airways limitation reversibility testing FEV1FVC
To analyse the incidence and the severity of asthma exacerbations
To analyse the use of rescue medication
To analyse the use of systemic corticosteroids
To assess healthcare resource utilisation
To assess treatment satisfaction with Trimbow
To assess tolerability of Trimbow This is a non-interventional longitudinal international multicentre study with prospective data collection At baseline the patients medical history with spe-cial focus on asthma will be collected The study baseline visit is at the time point of start of treatment with Trimbow Trimbow treatment may have started up to a maximum of 4 weeks prior to inclusion of the patient into this NIS
The planned observational period per patient should be at least 52 weeks ob-servational period OP I of the study and can be extended to up to 3 years OP II of the study During the observational period data may be collected approximately every 3 months during the first year OP I of the study and thereafter every 6 months OP II of the study The present observational plan does not stipulate any study-related procedures or defined time points only data that are available within the current clinical routine will be collected as documented in the patients files
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