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

NCT06100042 | Active Not Recruiting

• 2 other identifiers: CHIT-2301NIS 005 Pn
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Asthma

Keywords

Asthma; Triple Therapy; Beclomethasone; Formoterol; Glycopyrronium; Real-world; Single-Inhaler; Quality of life; Control of asthma; Adherence

Outcome Measures

Primary Outcomes (1)

• Patient demographics

  12 months

Secondary Outcomes (7)

• Assessment of asthma control using Asthma Control Test (ACT)

  12 months

• Assessment of quality of life using Mini Asthma Quality of Life Questionnaire (Mini AQLQ)

  12 months

• Assessment of adherence to treatment using 12-item Test of Adherence to Inhalers (TAI-12)

  12 months

• Incidence of asthma exacerbations

  12 months

• Asthma exacerbations

  12 months

Study Arms (1)

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

Interventions

BDP/FF/G DRUG

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).

Also known as: Trimbow

Asthma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Italia: lead
• Gesellschaft für Therapieforschung mbH: collaborator

Study Sites (1)

U.O. Clinica Psichiatrica e SPDC. Ospedale Policlinico S. Martino - IRCCS, Genova

Genoa, Italy

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 25, 2023
• Study Start: April 24, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)