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

Asthma Clinical Trial

— TRIMAXIMIZE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06100042
• Other study ID #: CHIT-2301
• Secondary ID: NIS 005 Pn
• Status: Recruiting
• Start date: April 24, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: June 2024
• Source: Chiesi Farmaceutici S.p.A.
• Contact: Clinical Trial Info
• Phone: 0521 2791
• Email: clinicaltrials_info[@]chiesi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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).

Locations

Country	Name	City	State
Italy	U.O. Clinica Psichiatrica e SPDC. Ospedale Policlinico S. Martino - IRCCS, Genova	Genoa

Sponsors (2)

Lead Sponsor	Collaborator
Chiesi Italia	Gesellschaft für Therapieforschung mbH

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient demographics		12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of asthma exacerbations	Number of exacerbations	12 months
Secondary	Asthma exacerbations	Occurrence of asthma exacerbations	12 months
Secondary	Adverse events	Number of AEs	12 months
Secondary	Adverse drug reactions to BDP/FF/G	Number of ADRs	12 months