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

NCT ID: NCT06100042

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2026-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

BDP/FF/G

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Trimbow

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 (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gesellschaft für Therapieforschung mbH

INDUSTRY

Sponsor Role: collaborator

Chiesi Italia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Genoa, , Italy

Countries

Italy

Other Identifiers

NIS 005 Pn

Identifier Type: OTHER

Identifier Source: secondary_id

CHIT-2301

Identifier Type: -

Identifier Source: org_study_id