TriMaximize: A Multicentre, Prospective, Non-interventional Trial in Asthma Patients (Trimaximize PL)

TriMaximize: 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.

TriMaximize: 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 Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: Trimbow

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 4/5 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, RV/TLC)
• To analyse parameters of asthma-related airway inflammation (FeNO)
• To analyse parameters of persistent airways limitation (reversibility testing FEV1/FVC)
• 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 patient's 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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Tomasz Debowski, Md Phd; Phone Number: +48-800 506 122 982; Email: t.debowski@chiesi.com
• Study Contact Backup: Name: Maciej Wojakiewicz, Phd; Phone Number: +48-800 697 400 054; Email: m.wojakiewicz@chiesi.com

Study Locations

• Poland
  • Tarnowskie Gory, Poland, 42-609
    • Recruiting
    • Indywidualna Specjalistyczna Praktyka Lekarska
    • Contact: Szymon Płaczek, MD; Phone Number: +48 607-931-761; Email: placzek@interia.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult asthmatic patients

Description

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Primary outcome measures include: Descriptive analisys of patients demografic Descriptive analisys of patient demographic	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess asthma control (ACT)	- Assess asthma control (ACT) - Change from baseline in ACT scores	12 months
Assess quality of life To measure the functional impairments	- Assess quality of life - Change from baseline in Mini-AQLQ scores	12 months
Treatment adherence	- Assess treatment adherence - Change from baseline in TAI scores	12 months
Lung function	- Analyse parameters of lung function using spirometry - Change from baseline in FEV1	12 months
Small airways parameters	- 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
Airway inflammation	- 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
Persistent airflow limitation	- 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
Asthma exacerbations	- Analyse the incidence of asthma exacerbations - Number of exacerbations 12 months prior to baseline and during study	12 months
Rescue medication use	- 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
Systemic corticosteroids use	- Analyse use of systemic corticosteroids - Use of any systemic corticosteroids 12 months prior to baseline and during study	12 months
Adverse events occurence	- Assess adverse events associated with use of Trimbow - Assessment of the number and type of adverse events	12 months
Retention rate with Trimbow	- Assess retention rate with Trimbow - Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12	12 months

Collaborators and Investigators

• Sponsor: Chiesi Poland Sp. z o.o.
• Collaborators: Gesellschaft für Therapieforschung mbH

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: NIS 005 Pn (Other Identifier: International unique identifier (Chiesi))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No