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

Recruiting

• Conditions: Asthma
• Interventions: Drug: BDP/FF/G

• Registration Number: NCT06100042
• Lead Sponsor: Chiesi Italia

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-25
• Study Start: 2024-04-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Patient demographics	12 months

Secondary Outcome Measures

Name	Time	Method
Assessment of asthma control using Asthma Control Test (ACT)	12 months	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.
Assessment of quality of life using Mini Asthma Quality of Life Questionnaire (Mini AQLQ)	12 months	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.
Assessment of adherence to treatment using 12-item Test of Adherence to Inhalers (TAI-12)	12 months	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).
Incidence of asthma exacerbations	12 months	Number of exacerbations
Asthma exacerbations	12 months	Occurrence of asthma exacerbations
Adverse events	12 months	Number of AEs
Adverse drug reactions to BDP/FF/G	12 months	Number of ADRs

Trial Locations

Locations (1)

U.O. Clinica Psichiatrica e SPDC. Ospedale Policlinico S. Martino - IRCCS, Genova; 🇮🇹 Genoa, Italy