Observational Study on Therapy Pathways of Asthamics Treated With ICS/LABA/LAMA Therapy in a Real-world Setting (TRIMAXIMIZE)

Multicentre, Prospective, Non-interventional Study 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 Outcomes

TriMaximize is a non-interventional study aimed to collect prospective data from asthmatic patients under routine care, for whom their treating physician has decided to prescribe BDP/FF/G (beclomethasone/formoterol/glycopyrronium).

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: BDP/FF/G

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Clinical Trial Info; Phone Number: +39 0521 2791; Email: clinicaltrials_info@chiesi.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnosis of moderate to severe asthma treated with BDP/FF/G as per clinical practice.

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 (BDP/FF/G) MS or HS according to its current authorised indication and current reimbursement conditions within the Italian National Health System. The treatment decision must be made independently from participation in this study and may have started within the previous 4 weeks (maximum);
• 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 enrolment 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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Asthma patients; Adult patients with a diagnosis of moderate to severe asthma treated with BDP/FF/G medium strength or high strength as per clinical practice.

Drug: BDP/FF/G; BDP/FF/G is an extrafine single inhaler triple therapy available in two dosage strengths: Medium strength (MS) containing 100 µg of beclomethasone dipropionate, 6 µg of formoterol fumarate dihydrate and 10 µg of glycopyrronium (as 12.5 µg glycopyrronium bromide);; High strength (HS) containing 200 µg of beclomethasone dipropionate, 6 µg of formoterol fumarate dihydrate and 10 µg of glycopyrronium (as 12.5 µg glycopyrronium bromide).; Other Names: Trimbow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient demographics	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of asthma exacerbations	Number of exacerbations	12 months
Adverse events	Number of AEs	12 months
Adverse drug reactions to BDP/FF/G	Number of ADRs	12 months
Assessment of asthma control using Asthma Control Test (ACT)	Change from baseline in ACT scores. The ACT is a self-report questionnaire with scores ranging from 5-25 (higher is better). Scores of 20-25 are classified as well-controlled; 16-19 as not well-controlled; and 5-15 as very poorly controlled asthma. The minimum clinically important difference is considered to be 3 point.	12 months
Assessment of quality of life using Mini Asthma Quality of Life Questionnaire (Mini AQLQ)	Change from baseline in MiniAQLQ scores. The MiniAQLQ is a disease specific questionnaire that consists of 15 asthma-related questions. Participants respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated better quality of life. A change in the score greater than 0.5 can be considered clinically important.	12 months
Assessment of adherence to treatment using 12-item Test of Adherence to Inhalers (TAI-12)	Change from baseline in TAI-12 score. The 12-item TAI comprises a patient domain (10 items) and a healthcare professional domain (2 items). Each item ranges from 1 (lowest adherence) to 5 (highest adherence) points. The patient domain score ranges from 10 to 50. Adherence is rated as good (score = 50), intermediate (score = 46-49).	12 months
Asthma exacerbations	Occurrence of asthma exacerbations	12 months

Collaborators and Investigators

• Sponsor: Chiesi Italia
• Collaborators: Gesellschaft für Therapieforschung mbH

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Adherence; Asthma; Quality of life; Formoterol; Beclomethasone; Glycopyrronium; Real-world; Triple Therapy; Single-Inhaler; Control of asthma
• 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: CHIT-2301; NIS 005 Pn (Other Identifier: International study code)

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