Clinical trial NCT05728749: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ASTHMA
Keywords: ASTHMA
TRIMBOW
TRIPLE THERAPY
BECLOMETHASONE
FORMOTEROL
GLYCOPYRRONIUM
TRIMAXIMIZE
REAL-WORLD SETTING
EXTRAFINE
SINGLE-INHALER
COHORT
PROSPECTIVE
Lead sponsor: Chiesi SAS
Sponsor class: INDUSTRY
Collaborators: name: Gesellschaft für Therapieforschung mbH
First posted: 2023-02-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will only be included in the Non-Interventional Trial if Trimbow® has been prescribed in line with its current marketing authorisation and the guidance specified in the summary of product characteristics (SmPC).

Physicians are urged to offer enrolment to all of their eligible patients consecutively as they present for their routine visit, and not select patients from their patient database.

Eligible patients may only be included in the NIT after providing written (witnessed, where required by law or regulation), IEC-approved informed consent.

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Assess asthma control (ACT)
timeFrame: 12 months
measure: Assess quality of life
timeFrame: 12 months
measure: Assess treatment adherence
timeFrame: 12 months
measure: Analyse parameters of lung function using spirometry
timeFrame: 12 months
measure: Analyse parameters of small airways disease
timeFrame: 12 months
measure: Analyse parameters of asthma-related airway inflammation
timeFrame: 12 months
measure: Analyse parameters of persistent airflow limitation
timeFrame: 12 months
measure: Analyse the incidence of asthma exacerbations
timeFrame: 12 months
measure: Analyse the severity of asthma exacerbations as defined by the American Thoracic Society/European Respiratory Society (ATS/ERS) classification of asthma exacerbations
timeFrame: 12 months
measure: Analyse use of rescue medication
timeFrame: 12 months
measure: Analyse use of systemic corticosteroids
timeFrame: 12 months
measure: Assess adverse events associated with use of Trimbow
timeFrame: 12 months
measure: Assess retention rate with Trimbow
timeFrame: 12 months
Other outcomes:
Locations:
city: Bois-Colombes
country: France
facility: ChiesiFrance
Study officials:
affiliation: University Hospital, Montpellier
name: Arnaud BOURDIN, Pr
role: PRINCIPAL_INVESTIGATOR
References: