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

N/AActive Not RecruitingNCT06100042

Chiesi Italia200 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Asthma

Interventions

BDP/FF/GDRUG

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Genoa, Italy

Outcomes

Primary Outcomes

Patient demographics

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 12 months

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.

Time frame: 12 months

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).

Time frame: 12 months

Incidence of asthma exacerbations

Number of exacerbations

Time frame: 12 months

Asthma exacerbations

Occurrence of asthma exacerbations

Time frame: 12 months

Data from ClinicalTrials.gov

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