A Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Out-comes

Chiesi UK147 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

147

Conditions

Asthma

Interventions

Non-interventionalOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients ≥ 18 years of age, 2. Patients with confirmed leading diagnosis of asthma with or without concomitant COPD, 3. 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, 4. Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study. Exclusion Criteria: 1\) 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.

Locations (1)

The Haven Surgery, The Haven, Burnhope,

Durham, County Durham, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

Assess asthma control (ACT)

Change from baseline in ACT scores

Time frame: 12 months

Assess quality of life

Change from baseline in Mini-AQLQ scores

Time frame: 12 months

Assess treatment adherence

Change from baseline in TAI scores

Time frame: 12 months

Analyse parameters of lung function using spirometry

Change from baseline in FEV1

Time frame: 12 months

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

Time frame: 12 months

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

Time frame: 12 months

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

Data from ClinicalTrials.gov

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