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

Sponsor

Chiesi Italia (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06100042

Collaborator

Gesellschaft für Therapieforschung mbH (Industry)

200

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: BDP/FF/G

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 31, 2024

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Patient demographics [12 months]

Secondary Outcome Measures

Assess asthma control (ACT) [12 months]
Change from baseline in ACT scores.
Assess quality of life (Mini-AQLQ) [12 months]
Change from baseline in Mini-AQLQ scores.
Assess treatment adherence (TAI-12) [12 months]
Change from baseline in TAI scores.
Incidence of asthma exacerbations [12 months]
Number of exacerbations
Severity of asthma exacerbations [12 months]
Severity of exacerbations
Adverse events [12 months]
Number of AEs
Adverse drug reactions to BDP/FF/G [12 months]
Number of ADRs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.