A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes

ASTHMA Clinical Trial

Official title:

A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728749
• Other study ID #: NIS 005 Pn
• Secondary ID: 564_TriMaximize_
• Status: Recruiting
• Start date: March 3, 2023
• Est. completion date: March 2025

Study information

• Verified date: July 2023
• Source: Chiesi SAS
• Contact: Christine CONTRE, Dr
• Phone: +33675085149
• Email: c.contre[@]chiesi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).

Description:

TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).

Trimbow is a fixed triple therapy containing a long-acting muscarinic antagonist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclometasone).

Asthma patients often need to use multiple inhalers as part of their therapy, which require different inhalation techniques. It has been shown that the use of several inhalers of different mode of action, design and dosage requirements may have a detrimental effect on patient adherence and subsequent treatment outcomes.

In this prospective, non-interventional trial, the investigators aim to evaluate aspects of adherence to Trimbow, a single-inhaler triple therapy (SITT) as a maintenance treatment of asthma, to gather knowledge from routine care on whether appropriate step-up to SITT leads to greater adherence and better health outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 18 years of age,

• Patients with confirmed leading diagnosis of asthma with or without concomitant COPD,

• Physician decision to start fixed triple therapy with ICS/LABA/LAMA (Trimbow® MS or HS) according to its current authorised indication. The treatment decision must be made independently from participation in this NIS,

• Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study,

• Patient must be covered by a social security scheme,

• Patient must be treated by one of the practitioners of the centre (at office or at hospital).

Exclusion Criteria:

• Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.

• Patients unable to understand scope of study or patients unwilling to participate in study.

Related Conditions & MeSH terms

• ASTHMA

Intervention

Other:
• Non-interventional
As this is a non-interventional trial, only data obtained within the current routine management of asthma at outpatient respiratory centres or GP centres will be documented.

Locations

Country	Name	City	State
France	ChiesiFrance	Bois-Colombes

Sponsors (2)

Lead Sponsor	Collaborator
Chiesi SAS	Gesellschaft für Therapieforschung mbH

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe patient characteristics and therapy pathways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice	Descriptive analysis of patient demographics.	12 months
Secondary	Assess asthma control (ACT)	Change from baseline in ACT scores.	12 months
Secondary	Assess quality of life	Change from baseline in Mini-AQLQ scores.	12 months
Secondary	Assess treatment adherence	Change from baseline in TAI scores.	12 months
Secondary	Analyse parameters of lung function using spirometry	Change from baseline in FEV1.	12 months
Secondary	Analyse parameters of small airways disease	Change from baseline in small airway function measured by pre-dose AUCAX (Area under the curve of reactance) using available oscillometry system.	12 months
Secondary	Analyse parameters of asthma-related airway inflammation	Change from baseline in percentage of patients with a fraction of exhaled nitric oxide (FeNO) below or above 20 ppb.	12 months
Secondary	Analyse parameters of persistent airflow limitation	Change from baseline in percentage of patients with persistent airflow limitation (PAL); PAL defined as post-BD FEV1 <80% predicted and post-BD FEV1/FVC Ratio < 0.7.	12 months
Secondary	Analyse the incidence of asthma exacerbations	Number of exacerbations 12 months prior to baseline and during study.	12 months
Secondary	Analyse the severity of asthma exacerbations as defined by the American Thoracic Society/European Respiratory Society (ATS/ERS) classification of asthma exacerbations	Severity of exacerbations, defined according to the ATS/ERS classification of asthma exacerbations, will be analysed 12 months prior to baseline and during study.	12 months
Secondary	Analyse use of rescue medication	Use of any rescue medication 7 days prior to baseline and during study 7 days prior to respective visit.	12 months
Secondary	Analyse use of systemic corticosteroids	Use of any systemic corticosteroids 12 months prior to baseline and during study.	12 months
Secondary	Assess adverse events associated with use of Trimbow	Assessment of the number and type of adverse events.	12 months
Secondary	Assess retention rate with Trimbow	Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12.	12 months